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CTRI Number  CTRI/2025/07/090304 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   How Traditional Ayurvedic Therapies May Help Older Adults Regain Strength: A Clinical Study. 
Scientific Title of Study   Evaluation of Bala Taila Abhyanga and Sarvanga Bashpa Sveda on Muscle Tone and Grip Strength in Geriatric Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akash K 
Designation  PG Scholar 
Affiliation  Dr D Y Patil College of Ayurved and Research Center Pimpri Pune 
Address  Rachana Sharir Department, Dr D Y Patil College of Ayurved and Research Center Pimpri Pune Dr D Y Patil Vidyapeeth Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9894217998  
Fax    
Email  akashvanaja07@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh Kutte 
Designation  Professor 
Affiliation  Dr D Y Patil College of Ayurved and Research Center Pimpri Pune 
Address  Rachana Sharir Department, Dr D Y Patil College of Ayurved and Research Center Pimpri Pune Dr D Y Patil Vidyapeeth Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9403984664  
Fax    
Email  yogesh.kutte@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh Kutte 
Designation  Professor 
Affiliation  Dr D Y Patil College of Ayurved and Research Center Pimpri Pune 
Address  Rachana Sharir Department, Dr D Y Patil College of Ayurved and Research Center Pimpri Pune Dr D Y Patil Vidyapeeth Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9403984664  
Fax    
Email  yogesh.kutte@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr D Y Patil College of Ayurved and Research Centre, Pimpri, Pune, Maharashtra, India 411018 
 
Primary Sponsor  
Name  CCRAS PG-STAR 
Address  PG-STAR Team Central Council for Research in Ayurvedic Sciences (CCRAS) Ministry of AYUSH, Govt. of India, Headquarters, Opposite Janakpuri-D Block, New Delhi-110058. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akash K  Dr D Y Patil College of Ayurved and Research Center Pimpri Pune  Rachana Sharir Department, Dr D Y Patil College of Ayurved and Research Center Pimpri Pune Dr D Y Patil Vidyapeeth Pimpri Pune 411018
Pune
MAHARASHTRA 		 9894217998

akashvanaja07@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr DYPCA and RC Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: BALAHANIH (KEVALAVATA),  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-aBya~ggaH, अभ्यंग  (Procedure Reference: Caraka sutram 5th chapter 85 t0 89th sloga, Procedure details: Bala taila is heated using the double boiling method until it gets lukewarm. Then the taila will be applied to the patient with the appropriate pressure depending upon the individual. Duration Upper and lower limbs – each limb for 5 minutes, the trunk for 5 minutes and the back for 5 minutes.)
(1) Medicine Name: Bala taila, Reference: Sharangadhara madhyama kanda 9th chapter 1st and 2nd sloga, Route: Topical, Dosage Form: Taila, Dose: 150(ml), Frequency: sos, Duration: 7 Days
2Intervention ArmProcedure-svedanam, स्वेदनम् (Procedure Reference: Haritha samhita chaturtha sthana 4th chapter 1st sloga, Procedure details: Duration till Samyak Sveda Lakshana attained.)
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients in the age category of 60 to 100 with generalized geriatric complaints like general body pain and insomnia or motor weakness for which Sarvanga Abhyanga and Bashpa Sveda has been advised 
 
ExclusionCriteria 
Details  Patients who are completely bedridden. Patients suffering from rheumatoid arthritis, paralysis, stroke and major neurological illness. Patients who have a surgical history of implants in limbs.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
There will be a notable difference of their grip strength before and after Bala taila abhyanga. Grip strength can be increased by 2 to 5 pounds (lbs).  Outcome will be assessed in 1st week 
 
Secondary Outcome  
Outcome  TimePoints 
Muscle tone can be increased benefits of abhyanga such as complexion strength can be achieved  Outcome will be assessed in 1st week 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
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   Phase 4 
Date of First Enrollment (India)   01/08/2025 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

This study is a single-arm clinical trial to evaluate the efficacy of Bala Taila Abhyanga and Sarvanga Baspa Sveda in geriatric patients with complaints of generalised geriatric complaints like general body pain, insomnia, or motor weakness. Patients with this complaint will be enrolled in the study, and sarvanga abhyanga with bala taila for 30 minutes and sarvanga baspa sveda till they reach samyak sveda lakshana will be given. And the primary outcome, which can be an improvement in grip strength of around 2 to 5 lbs., can be noted in 7 days, and the secondary outcome, which can be an improvement in muscle tone and achieving the effect of abhyanga, can be achieved in 7 days.

 
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