| CTRI Number |
CTRI/2025/06/088610 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
10/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Ayurveda interventions for chronic knee pain in elderly |
|
Scientific Title of Study
|
Evaluation of comparative efficacy of Ashwagandha versus Shallaki in chronic knee pain among older adults with knee osteoarthritis – A double-blind randomized controlled trial |
| 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 Pallavi Mundada |
| Designation |
Research Officer |
| Affiliation |
Central Council for Research in Ayurvedic Sciences |
| Address |
Room No. 106, CCRAS Headquarters, 61-65 Institutional Area, Opp D Block, Janakpuri, New Delhi
South West
DELHI
110058
India |
| Phone |
8956606123 |
| Fax |
|
| Email |
pallavimundada86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vaishali Kuchewar |
| Designation |
Professor and Head |
| Affiliation |
MGAC, DMIMS |
| Address |
Department of Kayachikitsa
Wardha
MAHARASHTRA
442001
India |
| Phone |
9420998747 |
| Fax |
|
| Email |
Vkuchewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharti |
| Designation |
Director |
| Affiliation |
Central Ayurveda Research Institute, CCRAS |
| Address |
Central Ayurveda Research Institute, Punjabi Bagh, New Delhi
West
DELHI
110026
India |
| Phone |
9868109737 |
| Fax |
|
| Email |
drbharti2@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Pallavi Mundada |
| Address |
Room No. 106, CCRAS Headquarters, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bharti |
CARI New Delhi |
OPD at the Central Ayurveda Research Institute, CCRAS, Road No. 66, Punjabi Bagh, New Delhi- 110026
West
DELHI |
0112522 5546
0112522 5546
cari.delhi2025@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M179||Osteoarthritis of knee, unspecified. Ayurveda Condition: SANDHIGATAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandha, Reference: Charak Samhita, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: water), Additional Information: - | | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Charak Samhita, Procedure details: Standard methodology for Abhyanga (massage) over Knee joint will be explained to the participant and a pictorial SOP (copy attached) and, a video for demo will be provided at baseline)
(1) Medicine Name: Til Taila, Reference: Charak Samhita, Route: Topical, Dosage Form: Taila, Dose: 2.5(ml), Frequency: bd, Duration: 45 Days | | 3 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Shallaki Extract, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 400(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Water), Additional Information: - | | 4 | Comparator Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Charak Samhita, Procedure details: Standard methodology for Abhyanga (massage) over Knee joint will be explained to the participant and a pictorial SOP (copy attached) and, a video for demo will be provided at baseline)
(1) Medicine Name: Tila Taila, Reference: Charak Samhita, Route: Topical, Dosage Form: Taila, Dose: 2.5(ml), Frequency: bd, Duration: 45 Days |
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Participants having pain in one or both knee joints since more than three months
Average severity of knee pain in the past week is reported more than four when assessed through Wong-Baker Faces
Participants scoring more than three in the Mini-Cog scale
Diagnosed cases of Knee osteoarthritis (OA) or those who fulfil the clinical American College of Rheumatology (ACR) criteria for knee osteoarthritis
Able to give written informed consent |
|
| ExclusionCriteria |
| Details |
Non-ambulatory patients
Participants showing severe osteoarthritis on radiological evaluation and eligible to be categorized as Grade-4 of Kellgren and Lawrence scale for OA (Antero-posterior X-Ray of the affected knee showing large osteophytes, marked narrowing of joint space, severe sclerosis and definite deformity of bone ends)
History of treatment with intra-articular injection of corticosteroids or hyaluronic acid or oral corticosteroids within a period of three months preceding study
Patients on regular intake of Ayurveda medicines (including any Ayurveda procedures) or physiotherapy (including therapeutic exercises) for pain relief in the past 2 weeks
Patients having unilateral/bilateral fixed flexion deformity in knees or metallic implant in knee joint; or severe deformity of lower limbs (e.g., knee varus or knee valgus)
History of knee joint replacement |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in score of Numeric Pain Rating Scale |
Baseline; at the end of Week 2, Week 4 and Week 6 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
KOOS
range of motion of the affected knee joint(s)
TUG
FTSST
Wellbeing Index
GSAQ
Comparison of frequency of use of conventional analgesic medicines as rescue medication for symptomatic relief in knee pain during the study period, with baseline and between the groups
Comparison of incidence of treatment emergent adverse events (like skin irritation, weight gain, gastric reactions, changes in vitals like blood pressure etc.) in both groups |
Baseline and at the end of six weeks |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
05/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a double blind randomized controlled study to determine the efficacy of Ashwagandha and Til taila abhyanga in chronic musculoskeletal pain associated with knee osteoarthritis among the elderly. The trial will be conducted as post-doctoral research as per the ICMR Bio-ethics guidelines. Total sample size that will be recruited in the trial is 72. The participants will be allocated to either group in 1:1 ratio. The trial arm will be compared with the control arm that will receive Boswellia serrata extract along with Til taila Abhyanga. The treatment duration will be for 6 weeks and follow-up will be by-weekly. The comparison of outcomes will be done at baseline and at the end of 6th week in both arms and between the groups. This study might be useful to explore the effects of a balya and rasayana medicine in alleviating symptoms and improving the functionality of the older adults suffering with chronic knee pain. |