|
 
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| ORIGINAL ARTICLE |
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| Year : 2022 | Volume
: 18
| Issue : 2 | Page : 49-57 |
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Safety and efficacy of ayush rasayana A and B in improving functionality of the elderly – A single-arm multicenter study
Aparajit B Dey1, Inderjeet Singh Gambhir2, Jayram Hazra3, Sakshi Sharma4, Pallavi S Mundada5, Sunita Mata5, Avinash Chakrawarty1, Om P Singh6, Achintya Mitra3, Rakesh K Rana7, Richa Singhal6, SK Vedi8, Ramavtar Sharma5, Adarsh Kumar5, Bharti Gupta4, Madan M Padhi5, Narayanam Srikanth5, Kartar Singh Dhiman6
1 Department of Geriatric Medicine, All India Institute of Medical Sciences, New Delhi, India
2 Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pardesh, India
3 Central Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, Kolkata, West Bengal, India
4 Department of Ayurveda, Central Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, New Delhi, India
5 Department of Ayurveda, Central Council for Research in Ayurvedic Sciences, New Delhi, India
6 Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pardesh, India
7 Department of Biostatistics, Central Council for Research in Ayurvedic Sciences, New Delhi, India
8 Department of Ayurveda, Regional Ayurveda Research Institute, Jaipur, India
| Date of Submission | 03-Feb-2022 |
| Date of Decision | 18-Apr-2022 |
| Date of Acceptance | 27-May-2022 |
| Date of Web Publication | 15-Jul-2022 |
Correspondence Address:
Sakshi Sharma
Central Ayurveda Research Institute, Central Council for Research in Ayurvedic Sciences, Road No. 66, Punjabi Bagh, New Delhi - 110 026
India
 Source of Support: None, Conflict of Interest: None
DOI: 10.4103/jiag.jiag_5_22
Background: As per Ayurvedic classics, Rasāyana is a term used for unique therapeutic measures intended to improve cognition, memory, physical strength and delay the degenerative processes. Ayush Rasayana A & B are developed from extracts of herbs pertaining rasayana property. Aims & Objectives: To assess the safety and effectiveness of 'Ayush Rasayana A and B' in improving physical endurance, quality of life and cognition of elderly. Materials and Methods: This is an open label, single arm, multi-centre study among 256 apparently healthy elderly between 60-75 years. Ayush Rasayan A was given for 6 days and Ayush Rayana B for 180 days. The effect of the trial drug was seen on functional capacity, quality of life and cognitive function and, safety of the intervention was assessed through haematological and biochemical tests, clinical examination and incidence of adverse events. Results: Significant improvement in 6 minute walk test and HMSE score was observed at 187th as compared to baseline (p<0.0001). Quality of life of the participants especially in domains of physical health, social relationship and environment also improved at the end of intervention period (p<0.0001). The haematological and bio-chemical parameters showed no significant changes as compared to baseline and no adverse events were observed during the study. Conclusion: Ayush Rasayana A and Ayush Rasayana B, both were well tolerated by all the participants. This ayurvedic intervention can be safely given to apparently healthy elderly to improve their functionality, quality of life and cognition. However, a randomized controlled trial is warranted to substantiate the efficacy of this drug.
Trial Registration: CTRI/2015/04/005679 dated 8th April 2015.
Keywords: Ageing, Ayurveda, cognition, functional capacity, Geriatric, quality of life
How to cite this article:
Dey AB, Gambhir IS, Hazra J, Sharma S, Mundada PS, Mata S, Chakrawarty A, Singh OP, Mitra A, Rana RK, Singhal R, Vedi S K, Sharma R, Kumar A, Gupta B, Padhi MM, Srikanth N, Dhiman KS. Safety and efficacy of ayush rasayana A and B in improving functionality of the elderly – A single-arm multicenter study. J Indian Acad Geriatr 2022;18:49-57 |
How to cite this URL:
Dey AB, Gambhir IS, Hazra J, Sharma S, Mundada PS, Mata S, Chakrawarty A, Singh OP, Mitra A, Rana RK, Singhal R, Vedi S K, Sharma R, Kumar A, Gupta B, Padhi MM, Srikanth N, Dhiman KS. Safety and efficacy of ayush rasayana A and B in improving functionality of the elderly – A single-arm multicenter study. J Indian Acad Geriatr [serial online] 2022 [cited 2023 Jun 6];18:49-57. Available from: http://www.jiag.com/text.asp?2022/18/2/49/351072 |
| Introduction | |  |
By the year 2050, the world population of adults older than 65 years will comprise 1/5th of the global population. In the Indian scenario, number of older adults 60 and above will increase from 10.11% to 21.5% of India's total population by 2050 (United Nations Population Division), meaning around 320 million elderly people. However, the proportion of the “oldest old” adults (age 80 years and above) has more than doubled over the past 65 years. It was 0.4% of the total population in 1950 and now is 0.96% in 2020. It is projected that by 2050, the population of this group will be nearly 40 million, i.e., almost 3% of the total population of India (World Population Prospects, 2019).
According to Ayurveda, even if the process of growing old is “natural,” but it is not necessary that old age should always be surrounded by various diseases and health caregivers. This third and last stage of life can be full of health and happiness if all the four components of life, namely the body, sense organs, mind, and the spirit are properly taken care of, throughout the life span. In this context, a 13th-century scholar of Ayurveda, Shārangdhara, had stated an important concept of decadal degradation of various aspects of the body and mind chronologically.[1] Ideally, aging should involve avoidance of disease and disability and maintenance of cognitive and physical function with sufficient social and productive activities. Age-related diseases are being more prevalent due to increased life expectancy in humans. Currently, one of the leading causes of morbidity and death worldwide are age related. Therefore, there is an urgent need to find apt interventions that help in reducing the incidence of debilitating age-related diseases.[2]
Aging process and the stage of old age are natural. Progressive senescence happening at natural pace is the “Kālaj Jara” and is inevitable (Nishpratikārya),[3] so the process of aging can only be slowed down and cannot be averted completely. Eating, drinking, and sleeping properly as well as administering rasāyana are the deeds that can be done to manage the above-said conditions.[4] Ayurveda has tried to explain what exactly happens when the same person crosses two stages of life or age that is childhood and youth (Bālya and Youvan) and enters the third and last one, the old age (Vriddha). The same food digested by the same body produces the same nourishing juices absorbed in the same way, gradually slows down its function of building up of tissues. In old age, the food only nourishes for maintenance of life, i.e., to keep the tissues alive and working and not for anabolism, because of the complete maturity of all the tissues in this stage of life (Paripakwa sharir).[5]
“Jarā chikitsā” (Geriatrics) is an ancient subject being studied for thousands of years in Ayurveda. All the medicines, food items, and deeds (aushadhi, ahāra, and vihāra) that enhance the quality of life (QOL) and facilitate longevity, are studied in this domain of Ayurveda.[6] Geriatrics and gerontology was a full-fledged branch of the Indian traditional medical science that was studied by specialists and scholars in ancient times, i.e., about 5000 years ago. Rasāyana is a term used for unique therapeutic measures intended to delay the degenerative processes causing aging.[7] As it is stated that the drugs which lead to healthy life up to 100 years or beyond that, delay the aging process, especially along with improvement in cognition, memory, physical strength, and also pacify disease are called as rasāyana drugs.[8] The Rasayana medicines (including diet, lifestyle, and medicines) also play role in maintaining QOL and enhancing the longevity of life in patients suffering from chronic diseases.[7] They are also attributed with therapeutic benefits in many diseases[9] Experimental studies have shown anti-inflammatory, anti-oxidant, and immuno-modulatory activities in many Rasayana drugs. Beneficial effects on cognitive functioning, physical fitness, and endurance are also proven through various research studies.[10]
There is a gradual loss of muscle mass, strength, and functionality with advancing age. As per Netuveli and Blane, aging does not influence QOL negatively with all other influences controlled, rather it is possible to enjoy a good quality long life. Hence, the maintenance and improvement of QOL should be one of the goals of clinical management.[11] Anti-aging potential of metformin, rapamycin, resveratrol, and one anti-aging component NAD + precursors is studied experimentally and the results revealed that these drugs have some efficacy in this respect. However to prove the anti-aging efficacy of such promising drug candidates, more longitudinal clinical trials, in humans are needed.[12]
On this background, this collaborative multicenter open-label clinical trial was conducted, with an objective to study the effect of a coded Ayurvedic polyherbal formulation Ayush Rasayan A and Ayush Rasayan B on aging with respect to functionality, cognition, and QOL of apparently healthy older adults.
| Subjects and Methods | | |
Study design
This was a prospective, open-label, single-group, pretest–posttest study. The trial was conducted at three centers in India for 39 months (April 22, 2015–July 24, 2018). The study was approved by the Institutional Ethics Committees of respective institutes and was also registered in the Clinical Trial Registry of India (CTRI/2015/04/005679) on April 8, 2015, prospectively.
Study participants
Inclusion criteria
Apparently healthy elderly participants between 60 and 75 years age of either sex who were willing to participate were included in the trial after obtaining their informed written consent.
Exclusion criteria
Hypertensive participants with blood pressure (BP) >160/100 mm of Hg, participants with hemoglobin <11 g%, participants with active/chronic liver, kidney disease or heart disease, nonambulatory, participants unable to go through the assessment, patients suffering from psychiatric diseases, and diabetic patients with fasting blood sugar more than 125 mg% and postprandial 200 mg% were excluded from the study.
A washout period of 2 weeks was given to the participants who were already receiving any kind of tonics/food supplements for general health improvement.
Sample size
Considering an average of 579 m in 6-min walk tests with a standard deviation (SD) of 165, it was assumed that the current intervention will increase the average walking in the elderly by 59 m.[13] At 95% confidence level (α = 0.05) and 80% power, the estimated sample size was 64 and expecting a 20% dropout rate, the number of patients to be enrolled in the study was calculated as 77. A round figure of 80 was taken for the final sample size at each center, so the total sample size was calculated as 240.
Study intervention
The trial drug AYUSH Rasayana A was given for 6 days immediately after induction in the study and subsequently, AYUSH Rasayana B was given for the next 180 days with lukewarm water to all the participants. Detailed information about the interventions is mentioned in [Table 1].
The preclinical acute, subacute, and chronic toxicity studies of both the formulations (AYUSH Rasayana A and B) done in mice and rats showed that the drugs are safe even on administering single dose at 10 times the recommended therapeutic dose (Reports attached as supplementary files).
Outcomes
The primary outcomes were, any change in the functional capacity and QOL of the participants at the end of the study. These outcomes were measured by comparing the distance covered in the 6-min walk test and WHOQOL-BREF score at baseline and on the 187th day. Secondary outcomes were any change in cognitive functioning assessed using the Hindi Mental State Examination (HMSE) scale, pro-inflammatory marker, namely high sensitivity C-reactive protein, and other laboratory investigations such as complete blood count, erythrocyte sedimentation rate, fasting, and postprandial blood sugars, glycosylated hemoglobin, serum lipids, blood urea, serum creatinine, serum cortisol, dehydroepiandrosterone-sulfate, serum total protein, serum albumin, serum globulin, creatinine clearance test, and any change in vital parameters such as systolic and diastolic BP, resting pulse rate, and pulse pressure after the completion of the study period to assess the safety of the intervention. ECG at baseline was also compared with that on the 187th day to observe any change in cardiovascular health.
The study procedure is described in [Figure 1]. A detailed general and systemic examination was done at each visit. The participants were also assessed for Ayurvedic parameters such as Prakriti (unique constitution of the body), Sāra (strength or excellence of dhatus, i.e., the fundamental elements), Satva (psychological strength), Sātmya (assessment of favorable/nonfavorable things), Samhanana (built), Āhāra Shakti (diet intake and digestion capacity), and Vyāyāma Shakti (capacity of doing physical activities). Āhāra Shakti was assessed by the average number of meals taken every day and the feeling experienced by the participant generally after taking meals. Vyāyāma Shakti was assessed from the grade of difficulty in climbing upstairs to the next floor or walking up to 100 yards and in doing their daily activities.
Statistical analysis
Descriptive data have been presented as numbers and percentages. The continuous data on outcome measures and safety parameters were checked for normality and were analyzed using paired t-test and were represented as mean (SD) if it followed normal distribution. Nonnormal data were analyzed using the Wilcoxon signed-rank test and have been presented as median (IQR). A P < 0.05 was considered statistically significant. All the data were analyzed using SPSS Version 15.0 (Statistical Package for Social Sciences by IBM Corporation Business Analytics Software).
| Results | | |
The CONSORT flow diagram of participants' recruitment in the study is shown in [Figure 2]. The enrolled participants were assessed at the baseline and at subsequent visits as described in [Figure 1]. Out of total of 292 participants enrolled, a statistical analysis of 256 participants (191 males and 65 females) was performed. To suffice the data of participants who dropped out during the course of the study, imputation by using the last observation carried forward method was applied on the participants who were assessed at least on the first follow-up visit.
Demographic and clinical characteristics
On analyzing the demographic data, it was found that majority of patients, i.e., 60.9% were in the age group of 60–65 years, followed by 21.9% in the age group 66–70 and 17.2% were of the age group 70–75. Most of the participants (93.8%) were literate. Sixteen of the patients were addicted to smoking, 13.3% to tobacco, 2.7% to alcohol, and 68% had no such addiction. About 35.5% of the participants had abnormal sleep patterns and 37.9% of patients had irregular bowel habits. Most of the participants were above the poverty line (91.8%) [Table 2].
Assessment of efficacy
There was a significant improvement in the six-minute walk test as observed by the increase in distance covered in 6 min on the 187th day (mean [SD] 485.97 (100.697)) as compared to baseline values of the mean (SD) (441.40 (94.665)) where P < 0.0001 [Table 3] and [Figure 3]. Similarly, analysis of the WHOQOL-BREF score, for assessing QOL, showed significant improvement in the physical health domain (mean score (SD) at baseline was 54.54 (10.248) and on the 187th day was 59.55 (9.263) where P < 0.001). In the domain related to social relationships, the mean (SD) of the score at baseline was 64.23 (15.118) and on the 187th day 70.61 (13.230) where P < 0.0001. Assessment of the fourth domain which is related to the environment also showed significant improvement (mean [SD] at baseline was 65.44 [12.578] and 187th day was 72.30 (13.253) where P < 0.001) [Table 3] and [Figure 4]. The assessment of cognition made by HMSE score also showed significant improvement (mean score at baseline 29.55 [2.756] and at 187th day 30.81 [2.327] [P < 0.001]) [Table 3]. The rise in the mean level of high sensitivity C-reactive protein, at the end of treatment, was also statistically significant. However, all the values, before and after the treatment, were within the normal limits so the rise is not of clinical significance.
At baseline majority of participants (68.8%) had madhyam āhāra shakti (moderate digestive capacity). However, it was observed that on the 187th day, majority of participants (52%) had pravara āhāra shakti (Good digestive capacity). Similarly, at baseline, majority of participants had madhyam vyāyāma shakti (moderate capacity of doing physical activities) but on the 187th day, majority of participants had pravara vyāyāma shakti (good capacity of doing physical activities) [Table 4].
Assessment of safety
The vital parameters of participants continued to remain within the normal limits. There was a significant decrease in mean systolic BP, but the values before and after the study period were within the normal range [Table 3].
Among the laboratory parameters assessed to evaluate the safety of the drug, the change in the values of packed cell volume, mean corpuscular hemoglobin concentration, red blood cell distribution width, serum creatinine, and serum uric acid on the 187th day were statistically significant when compared with the values of at baseline. There was no statistically significant difference in other hematological and biochemical parameters before and after the study [Table 5]. No adverse drug reaction was reported by any participant during the study period.
| Discussion | | |
The results of this study proved that the combination of Ayush Rasayana A and B, which is a coded Ayurvedic medicine, is likely to be effective in improving the general well-being of the elderly by enhancing their physical endurance, QOL, and cognition. The studied medicine was also found safe in apparently healthy older adults when administered in the prescribed dose. However, a controlled study is warranted for establishing the effectiveness of this Ayurvedic drug given the high plausibility of this large uncontrolled assessment indeed pointing toward benefit.
Several procedures such as augmentation of autophagy, elimination of senescent cells, transfusion of plasma from young blood, intermittent fasting, enhancing adult neurogenesis, physical exercise, antioxidant intake, and stem cell therapy are being studied for their anti-aging potential. Some of these candidates are ready for large-scale clinical trials for combating aging and postponing age-related diseases.[2]
The branch of Jarā chikitsā is also called Rasāyana Tantra in Ayurveda,[8] Rasāyana is defined as the way to build up all the tissues and make them work most efficiently. The term rasāyana actually means as the action of any drug that enhances the longevity of life, memory, cognitive functions of the brain, rejuvenates the body, its aura, strength, voice, sensory functions, etc.[9] Overall, the drugs which replenish and revitalize all the energy production and consumption systems of cells in different ways are said to be having rasāyana properties.
It is stated in Sushrut Samhita that, administering Rasayana without biopurification of body and mind is as good as coloring an unclean cloth.[14] Therefore, for the purpose of biopurification, initially Ayush Rasayan A which consisted of mild laxative drugs was given for 6 days immediately after recruitment. The effect of Ayush Rasayan B after administering Ayush Rasayan A, can be attributed to the mode of action of rasāyana drugs as stated in Charak Samhita (classical text of Ayurveda), that rasāyana drugs act by direct enrichment of the nutritional quality of the nutrient plasma (rasa), by promoting nutrition through improving the digestion and metabolism (agni) and by promoting the competence of the microcirculatory channels at tissue and cellular level (srotas).[9],[15] Rasāyana means the way of attaining excellent rasa by which, one attains longevity, memory, intelligence, freedom from disorders, youthful age excellence of luster, complexion and voice, and optimum strength of the body and sense organs. Thus, building up energy resources in the tissues and activating the energy consumption channels are the basic functions that can be attributed to the multidimensional effects of rasāyana drugs.[15] Ayush Rasayan B consists of extract of three herbs, namely, Āmalakī (Phyllanthus emblica L.), Aśvagandhā (Withania somnifera (L.) Dunal), and Guḍūcī (Tinospora sinensis (Lour.) Merr.)
Experimental studies have shown that aśvagandhā possesses anti-inflammatory, antitumor, antistress, antioxidant, immune-modulatory, hemopoietic, and rejuvenating properties and exerts a positive influence on the endocrine, cardiopulmonary, and central nervous systems.[16] A review article on the nootropic activity of herbs reports that Aśvagandhā (withanolide) is a paramount contestant for the treatment of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, cognitive deterioration and convulsions because it has the capacity to reassemble neural chains. Glucosides and sitoindosides present in Aśvagandhā reported to show antistress and antidepressant effects as well as have therapeutic effects on cognitive deterioration as well as on dementia.[17] In a placebo-controlled double-blind pilot study conducted on 50 adults, it was observed after 8 weeks that Aśvagandhā root extract when given 300 mg twice daily, proved to be effective in enhancing both immediate and general memory in people with mild cognitive impairment. It also improved the executive function, attention, and information processing speed of the participants.[18] Andallu and Radhika in a clinical study showed that the root of W. somnifera shows hypoglycemic, diuretic, and hypocholesterolemic activities with no clinically observed adverse effects.[19]
Tinospora cordifolia, boosts the mechanism of cognitive action as well as shows considerable antidepressant action through expanding brain monoamines according to the review article on the nootropic activity of herbs.[17] In phase 1 clinical study, it was observed that T. cordifolia could downregulate the overactivity of the sympathetic nervous system as compared to placebo and so it could be a candidate for daily consumption as a prophylactic agent to prevent the long-term chemical changes having adverse consequences on the heart and other organs due to chronic activation of the sympathetic nervous system.[20] A review evaluating the antioxidant potential of Rasayana drugs showed that Ashwagandha and Guduchi may be helpful in preventing oxidative stress and premature aging.[21]
Āmalakī Rasayan (AR) is an Ayurvedic formulation where Āmla powder is processed in fresh Āmla juice used in the Indian traditional system. In a study where freshly prepared AR was given to healthy elderly volunteers, for 45 days to test its influence on recognized DNA repair activities in healthy aged individuals, it was found that AR administration stably maintained/enhanced the UVC-induced DNA strand break repair in aged individuals without any adverse effects.[22] The anti-inflammatory effect of hydroalcoholic extracts of Emblica officinalis was when studied in rodent models of acute and chronic inflammation, potent anti-inflammatory activity was observed.[23]
This clinical trial was primarily aimed at evaluating the efficacy of Ayush Rasayana A and B in of the improve biological competence body through accelerated and appropriate nutrition. This was ascertained by improvement in functionality and QOL without causing any adverse effects in apparently healthy elderly participants. The study showed statistically significant improvement in distance covered in 6 min by the participants, their QOL and the cognitive capacity of the participants. This result can be attributed to the anti-inflammatory, adaptogenic, and nootropic activity of all the herbs in the formulation. The medicines were well tolerated by the participants throughout the study period as no significant change in the vital parameters and cardiovascular health (inferred by measuring respiratory rate, pulse rate, BP, and ECG) was observed on the 187th day when compared with baseline.
Limitations
As per Ayurvedic classical texts, Rasayana medications are best effective when given till middle age of life and after proper bio-purification and reinforcement of health to delay the aging process.[14],[24] In this perspective, the anti-aging effect of Rasayana medicines can be best evaluated by designing long-duration prospective studies, following up the younger adults who were administered Rasayana drugs in their middle age till 60 years of age. Another important fact about Rasayana administration is that, the participant has to adopt healthy lifestyle and diet as per Ayurveda to get complete benefits of the therapy, but in this study, the participants were not specifically advised for any such lifestyle and diet because, in the present study, we aimed at evaluating the efficacy and safety of one Ayurvedic combination (of the herbs having Rasayana like effects), in improving the functionality and QOL of the elderly.
| Conclusion | | |
Rasāyana Tantra, a specialized branch of Ayurveda that deals with aging uses a rich source of drugs, formulations, and various principles for the longevity of life span, improving physical strength, cognition, and memory, i.e., improving the functions of the brain and body as well as for treating various diseases in old age. This clinical trial conducted to evaluate the safety and efficacy of one such combination in 256 apparently healthy elderly participants, shows that Ayush Rasayana A and B show positive effects on the physical fitness, cognitive function, and QOL of the elderly and that this formulation can be safely given in apparently healthy older adults. These leads can be used to design and conduct a randomized controlled trial on a larger population to substantiate the effect of Ayush Rasayana A and B on healthy aging.
Acknowledgment
The authors are thankful to all the study participants for their participation in the study. We thank the Head of the Institute of all three study centers for providing their support. We also thank the Senior Research fellows Dr. Soniya, Dr. Pradeep Kumar Maddheshiya, Dr. Nivedita, and Dr. Chandreyee Ray for their contribution in data collection.
Financial support and sponsorship
This study was funded by the Central Council of Research in Ayurveda Sciences, Ministry of AYUSH, Government of India, New Delhi.
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4]
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]
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