CTRI/2025/05/086568 [Registered on: 08/05/2025] Trial Registered Prospectively
Last Modified On:
06/05/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda Yoga & Naturopathy
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
ASHIRWAD - Ayurveda for Sarcopenia & Holistic-health: Integrative Research on Wellness for Age-related Debility.
Scientific Title of Study
Efficacy of 6-month Holistic Ayurveda Intervention on Sarcopenia Related Clinical and Biochemical Outcomes among Elderly: A Multicentric Randomised Controlled Trial.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Monika Pathania
Designation
Additional Professor
Affiliation
All India Institute of Medical Sciences - Rishikesh
Address
Dept. of Geriatric Medicine, Level - 6, Academic Block Building - A, All India Institute of Medical Sciences, Virbhadra Marg, Rishikesh - 249203.
Dehradun UTTARANCHAL 249203 India
Phone
8126021556
Fax
Email
anshupathania27@gmail.com
Details of Contact Person Scientific Query
Name
Monika Pathania
Designation
Additional Professor
Affiliation
All India Institute of Medical Sciences - Rishikesh
Address
Dept. of Geriatric Medicine, Level - 6, Academic Block Building - A, All India Institute of Medical Sciences, Virbhadra Marg, Rishikesh - 249203.
Dehradun UTTARANCHAL 249203 India
Phone
8126021556
Fax
Email
anshupathania27@gmail.com
Details of Contact Person Public Query
Name
Sriloy Mohanty
Designation
Senior Medical Officer
Affiliation
All India Institute of Medical Sciences - Rishikesh
Address
Dept. of AYUSH, All India Institute of Medical Sciences, Virbhadra Marg, Rishikesh - 249203.
Dehradun UTTARANCHAL 249203 India
Phone
9560540977
Fax
Email
sriloy21@gmail.com
Source of Monetary or Material Support
AIIMS Rishikesh
Primary Sponsor
Name
ICMR
Address
V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India
Type of Sponsor
Government funding agency
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 3
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Monika Pathania
All India Institute of Medical Sciences
Department of Geriatric Medicine, 6th Floor, Academic Block Dehradun UTTARANCHAL
8126021556
anshupathania27@gmail.com
Dr Archana Singh
Uttarakhand Ayurved University
Room number 5, Ayurvedic diagnostics and clinical laboratory, Department of Rog Nidan and Vikriti Vigyan, Main Campus (Dehradun), Uttarakhand Ayurved University Dehradun UTTARANCHAL
7409570303
archana8580singh@gmail.com
Dr Sanjay Kumar Singh
Uttarakhand Ayurved University
Room number 19& 21, Ayurvedic diagnostics and clinical laboratory, Department of Rog Nidan and Vikriti Vigyan, Rishikul Campus (Haridwar), Uttarakhand Ayurved University, Haridwar Hardwar UTTARANCHAL
9415284453
drsanjaysingh1970@gmail.com
Details of Ethics Committee
No of Ethics Committees= 3
Name of Committee
Approval Status
AIIMS Rishikesh IEC
Approved
Institutional Ethics Committee of Faculty of Ayurveda, Main Campus
Approved
Institutional Ethics Committee of Faculty of Ayurveda, Rishikul Campus Haridwar
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition:M628||Other specified disorders of muscle. Ayurveda Condition: VARDHAKYAJANYARAJAYAKSHMA/JARASOSHAH,
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Intervention Arm
Procedure
-
piNDasvedaH, पिण्डस्वेदः Pradhan Karma
(Procedure Reference: Ayurvedic Treatment of Kerala, page: 5-6, Charak Samhita Sutrasthana: 14/25, Procedure details: 21 Shashtika Shali Pinda Sweda (SSPS) sessions conducted over the span of 6 months. The total duration of the procedure - 60 minutes. As per SOP) (1) Medicine Name: Ksheerbala Taila, Reference: Ayurvedic Treatment of Kerala, page: 5-6, Charak Samhita Sutrasthana: 14/25, Route: Topical, Dosage Form: Taila, Dose: 100(ml), Frequency: od, Duration: 21 Days(2) Medicine Name: Balamoola Kwatha, Reference: Ayurvedic Treatment of Kerala, Pages 5-6; Charaka Samhita, Sutrasthana: 14/25, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 2000(ml), Frequency: od, Duration: 21 Days(3) Medicine Name: Shashtika Shali, Reference: Ayurvedic Treatment of Kerala, page: 5-6, Charak Samhita Sutrasthana: 14/25 , Route: Topical, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 400(g), Frequency: od, Duration: 21 Days
2
Intervention Arm
Lifestyle
-
-
Dinacarya: Yoga Practice, Ritucarya: none, Acara Rasayana:Risk reduction counselling including dietary advice, Other:, Pathya/Apathya:no, Pathya:, Apathya:
3
Comparator Arm (Non Ayurveda)
-
Control Arm
Standard care, i.e., Risk reduction counselling including dietary advice and resistance exercise training for sarcopenia, will be provided by the doctors/investigators
(Procedure Reference: harak Samhita Sutra sthana: 5/12, Procedure details: The Patient will be self practising nitya abhyanga at their home as instructed by ayurveda expert. Ksheerabala oils 20ml daily will be used for Sthanika Abhyanga for 160 days. As per SOP) (1) Medicine Name: Ksheerbala Taila, Reference: harak Samhita Sutra sthana: 5/12, Route: Topical, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 180 Days
6
Intervention Arm
Procedure
-
mAtrAbastiH, मात्राबस्तिः
(Procedure Reference: Charak Samhita Siddhi sthana: 4/52, Procedure details: 21 Matra Basti sessions will be conducted over the span of 6 months. 60 ml of ksheerabala oil will be used, & the total duration of the procedure will be 10 minutes.) (1) Medicine Name: Ksheerbala Taila, Reference: Charak Samhita Siddhi sthana: 4/52, Route: Rectal, Dosage Form: Taila, Dose: 80(ml), Frequency: od, Duration: 21 Days
Inclusion Criteria
Age From
60.00 Year(s)
Age To
80.00 Year(s)
Gender
Both
Details
Older adults greater than 60 years old, both males and females, and able to walk independently.
Having SARC-F scores greater than 4
Having a smartphone and proficient in using a smartphone.
Willing to provide written informed consent and willing to comply with study procedures.
ExclusionCriteria
Details
Known cases of chronic kidney disease, chronic liver disease, primary, malignancy, osteoarthritis, HIV, on ICD and stroke.
Diagnosed cases of psychiatric disorders like severe depression, or any psychiatric illness that impairs interaction with others.
Active bacterial infections or sepsis as per IDSA guidelines , Cases of exfoliative Skin infections.,Recent trauma, fractures, Major surgeries (CABG, lower limb hip or knee replacement, renal transplants ) ,musculoskeletal pains or any dysfunction that prevents exercise.
Subjects on anabolic steroids, glucocorticoids, chemotherapy, antituberculosis drugs and thyroxine.
Known contraindications for SSPS as per Ayurveda texts.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Short Physical Performance Battery (SPPB): The Short Physical Performance Battery (SPPB) is an assessment tool that evaluates lower limb function through three components: balance tests, gait speed assessment, and chair rise exercises. Diminished SPPB scores suggest reduced physical capability and have been associated with sarcopenia—a condition characterized by loss of muscle mass and strength—as well as other negative health outcomes.
baseline; months 1,2,3,4,5,6 (endpoint)
Secondary Outcome
Outcome
TimePoints
Muscle Strength (Handgrip Strength):
Muscle strength will be assessed using a handheld dynamometer. Handgrip strength is a simple and commonly used measure of upper-extremity muscle strength, typically measured using a handheld dynamometer. Handgrip strength is associated with overall muscle strength and is a reliable indicator of functional status in older adults. Low handgrip strength is associated with an increased risk of disability, falls, and mortality. It is considered a key parameter in the diagnosis of sarcopenia.
baseline; months 1,2,3,4,5,6 (endpoint)
Physical Performance:
6-Metre Walk Test: Walking speed is a strong predictor of functional decline and mortality in older adults. Slower walking speed suggests compromised physical performance and may indicate the presence of sarcopenia. It is measured by the time taken to walk a distance of 6 metres at a usual level pace. A walking speed of less than 1.0 m/s is associated with sarcopenia. A sub-group of participants at AIIMS Rishikesh will undergo GAIT analysis using ProtoKinetics’ Zeno Walkway Gait Analysis System.
5-Time Chair Stand Test: This test assesses lower limb strength and functional ability. Slower performance may suggest muscle weakness and functional limitations associated with sarcopenia. It is measured by the time taken to stand up and sit down from a chair five times consecutively. Completing the test in 12 seconds or more is indicative of sarcopenia.
baseline; months 1,2,3,4,5,6 (endpoint)
Strength, assistance with walking, rising from a chair, climbing stairs, and falls (SARC-F) questionnaire: SARC-F is a screening tool for sarcopenia in older adults, assessing strength (S), assistance walking (A), rising from a chair (R), climbing stairs (C), and falls (F).
baseline; months 1,2,3,4,5,6 (endpoint)
Frailty Assessment and Screening Tool (FAST): FAST is a validated scale developed for assessing frailty among older adults, particularly in low- and middle-income countries like India. It underwent a rigorous development process and demonstrates strong psychometric properties, including high reliability and validity.
baseline; months 1,2,3,4,5,6 (endpoint)
Montreal Cognitive Assessment (MoCA): The MoCA test is a brief screening tool used to detect mild cognitive impairment and early dementia in elderly populations. It assesses various cognitive domains including memory, attention, language, visuospatial skills, executive function, and orientation.
baseline; months 1,2,3,4,5,6 (endpoint)
Mini Nutritional Assessment (MNA): The MNA is a screening tool designed to assess the nutritional status of older adults, aiding in the early detection of malnutrition or the risk of malnutrition.
baseline; months 1,2,3,4,5,6 (endpoint)
SarQOL (Sarcopenia and Quality of Life): The SarQOL is a tool designed to measure the impact of sarcopenia on the quality of life in older adults.
baseline; months 1,2,3,4,5,6 (endpoint)
Pittsburgh Sleep Quality Index
baseline; months 1,2,3,4,5,6 (endpoint)
Geriatric Depression Scale
baseline; months 1,2,3,4,5,6 (endpoint)
Appendicular Skeletal Muscle Mass (ASM): Appendicular skeletal muscle mass (ASM) will be measured using bioelectrical impedance analysis (BIA), which is an essential tool for assessing muscle mass.
Liver Function Test (LFT), Kidney Function Test (KFT)
baseline; 1 month, 3 month, 6 month (endpoint)
Addenbrooke Cognitive Examination
baseline; months 1,2,3,4,5,6 (endpoint)
Target Sample Size
Total Sample Size="222" Sample Size from India="222" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
07/07/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Sarcopenia, characterized by age-related muscle loss in quantity as well as quality, is reflected as diminished muscle function that results in poor physical performance as it becomes more severe. This condition affects 12.6% to 17.5% of elderly Indians. There is piling up evidence of sarcopenia and its association with geriatric syndromes like frailty that further lead to disability, falls, adverse health outcomes,poor quality of life,increased hospitalizations, and all cause mortality among the elderly population. Sarcopenia is identified as a substantial public health burden in the geriatric population. As per the Asian Working Group for Sarcopenia (AWGS) 2019 Consensus Guidelines, there is no standard pharmacological treatment for the same. Due to the paucity of standard treatment guidelines for sarcopenia, globally, lifestyle interventions, exercise, and nutritional advice are considered mainstays. AWGS also recommends exploring treatment modalities among Asians. With the rising burden of sarcopenia in India, tailored strategies are needed that integrate culturally accepted modalities like Ayurveda, offering a holistic solution with a backup of robust scientific evidence that is subsequently globally acceptable.
Novelty: The proposed study will be the first of its kind to investigate the effects of an Ayurvedic intervention on clinical outcomes in Sarcopenia. This will also be a novel study that investigates the effect of traditional Indian medicine on the pathophysiological mechanisms and biomarkers of Sarcopenia. Objectives:Primary: To determine the effect of 6-month Ayurveda intervention on key outcomes of Sarcopenia, i.e., muscle strength, physical performance, and appendicular skeletal muscle mass (ASM). Secondary: To determine change in Sarcopenia related inflammatory and oxidative stress markers, QOL, sleep quality, frailty and other psycho-cognitive parameters. Methods: In a multicentric randomised controlled trial, elderly individuals diagnosed with Sarcopenia (as per the AWGS 2019 guidelines) will be enrolled from three institutions. Baseline investigations of muscle strength, physical performance, ASM, inflammatory and oxidative stress markers, and questionnaires like SARC-F, FAST, ACE-III, MoCA, MNA, SarQOL, PSQI, GDS will be assessed. After randomization, the experimental arm will undergo a 6-month holistic Ayurveda intervention composed of Shashtika Shalli Pinda Sweda (SSPS) and Ashwagandha Churna Rasayana along with standard care, i.e., Risk reduction counselling including dietary advice and resistance exercise training for Sarcopenia, while the control arm will undergo standard care alone. Participants will be called for revisits on a monthly basis as per the strategic intervention plan. All participants will be followed up for 6 months, after which all the outcomes will be re-assessed.
Expected Outcomes: At the end of the trial, we expect a 20% improvement in the primary outcomes following the 6-month holistic ayurveda intervention, namely: muscle strength, physical performance, ASM. Sarcopenia related biochemical investigations of inflammatory and oxidative stress markers, QOL, sleep quality, frailty and other cognitive, psychological, and old-age related parameters are also expected to improve. Positive outcomes may pave the way for the standardisation of proposed intervention and help develop evidence-based recommendations for incorporating Ayurveda in the management of sarcopenia and other musculoskeletal issues related to old age, guiding clinical practice towards the use of evidence-based AYUSH protocols.