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CTRI Number  CTRI/2024/08/071782 [Registered on: 01/08/2024] Trial Registered Prospectively
Last Modified On: 08/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role Of Ashwagandha Milk To Manage Knee Joint Pain In Menopausal Woman  
Scientific Title of Study   A Randomized Control Clinical Trial To Evaluate The Effect Of Ashwagandha Ksheerapaka In Primary Osteoarthritis Of Knee In Menopausal Women  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ruchi purohit 
Designation  PhD Scholar 
Affiliation  G J Patel Institute Of Ayurvedic Studies And Research Centre 
Address  Department Of Kayachikitsa, G J Patel Institute Of Ayurvedic Studies And Research Centre, S G Patel Ayurvedic Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India
Department Of Kayachikitsa, G J Patel Institute Of Ayurvedic Studies And Research Centre, S G Patel Ayurvedic Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India
Anand
GUJARAT
388121
India 
Phone  9601510772  
Fax    
Email  ruchipurohit1710@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Manchak V Kendre 
Designation  Professor & HOD 
Affiliation  G J Patel Institute Of Ayurvedic Studies And Research Centre 
Address  Department Of Kayachikitsa, G J Patel Institute Of Ayurvedic Studies And Research Centre, S G Patel Ayurvedic Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India

Anand
GUJARAT
388121
India 
Phone  9429200112  
Fax    
Email  manchak.kendre@cvmu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Ruchi purohit 
Designation  PhD Scholar 
Affiliation  G J Patel Institute Of Ayurvedic Studies And Research Centre 
Address  Department Of Kayachikitsa, G J Patel Institute Of Ayurvedic Studies And Research Centre, S G Patel Ayurvedic Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India

Anand
GUJARAT
388121
India 
Phone  9601510772  
Fax    
Email  ruchipurohit1710@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  G J Patel Institute Of Ayurvedic Studies And Research Centre 
Address  Department Of Kayachikitsa G J Patel Institute Of Ayurvedic Studies And Research Centre S G Patel Ayurvedic Hospital And Maternity Home New Vallabh Vidyanagar Anand Gujarat India 
Type of Sponsor  Private medical college 
 
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 Ruchi purohit  S G Patel Ayurveda Hospital and Maternity Home   Room No 14 Kayachikitsa OPD S G Patel Ayurveda Hospital and Maternity Home New Vallabh Vidyanagar
Anand
GUJARAT 		 9601510772

ruchipurohit1710@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL (HUMAN) ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:M170||Bilateral primary osteoarthritis of knee. Ayurveda Condition: SANDHIGATAVATAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: ASHWAGANDHA , Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Shatavari, Reference: Bhavprakash Nighantu, Route: Oral, Dosage Form: Ksheerpaka, Dose: 100(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Goghrita), Additional Information: -
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Menopausal woman having signs and symptoms of primary osteoarthritis of knee.
1 Age group 45-70 year.
2 Amenorrhea for ≥12 months
3 Diagnosed cases of OA of knee willing to participate in the study and have completed the consent
form were selected.
4 Kellgren Lawrence scale grade1 to 3 
 
ExclusionCriteria 
Details  Any history of osteotomy/arthroplasty
➢ Secondary osteoarthritis (rheumatoid arthritis, psoriatic arthritis, systemiclupus erythematosus)
➢ Obesity (BMI more than 28)
➢ Kellgren Lawrence scale grade 4 cases.
➢ Patient on medication which interferes the result.
➢ Patient with associated major disorders. (e.g. uncontrolled DM, HTN, CCF, COPD, AIDS, STDS,
CARCINOMA etc) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in subjective and objective parameters used for primary
osteoarthritis of knee in post-menopausal women.
 		 30th day,60th day,90th day.
 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in quality of life in menopausal women.  90 days. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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 2/ Phase 3 
Date of First Enrollment (India)   28/08/2024 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
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   India is expected to be the chronic disease capital, with 60 million people with arthritis, by 2025.
Knee osteoarthritis (OA) is the most frequent kind of arthritis and is a main reason for disability that abridged the quality of life.
Osteotomy, unicondylar and total knee replacements are commonly done by orthopaedic surgeons across the country. Ashwagandha (W. Somnifera) has been prescribed for a variety of musculoskeletal conditions (e.g., arthritis, rheumatism), and as a general tonic to improve overall health.
The current standard treatment of post-menopausal osteoarthritis (knee OA) is pharmacological modalities like analgesics, NSAID’s, topical applications, physiotherapy.
Osteoarthritis (knee OA) after menopause is being globally common and its present standard treatment having palliative effects, results of this study could offer a safer, herbal alternative.
In Ayurvedic classics Ashwagandha is reported having Shothahara, Vedanasthapana, Mastishkashamaka, Deepana, Anulomana, Shoolaprashmana, Kaphaghna,,Garbhashayashothahara, Yonishoolahara, Mootrala, Balya, Brinhana, Rasayana activities. There has not been any study conducted on effect of Ashwagandha Ksheerapaka in primary osteoarthritis of knee in menopausal women. 
 
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