| CTRI Number |
CTRI/2025/04/085955 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| 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
|
A study to evaluate the effect of Chitrak root gel as compared to Diclofenac gel for knee joint pain relief |
|
Scientific Title of Study
|
Multicentric, randomized, double-blind, parallel-group, controlled trial to evaluate efficacy and safety of gel containing Plumbago zeylanica root for mild to moderate osteoarthritis of knee |
| 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 Harsha Hegde |
| Designation |
Scientist F |
| Affiliation |
ICMR National Institute of Traditional Medicine Belagavi |
| Address |
N210, 2nd floor, Block 1, Department of Ethnomedicine, ICMR National Institute of Traditional Medicine, Opp KLE campus, Nehrunagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439220 |
| Fax |
|
| Email |
harshah@icmr.gov.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Barvaliya |
| Designation |
Scientist E |
| Affiliation |
ICMR National Institute of Traditional Medicine Belagavi |
| Address |
W309, 3rd floor, Block 1, Department of Health Systems Research, ICMR National Institute of Traditional Medicine, Opp KLE campus, Nehrunagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439234 |
| Fax |
|
| Email |
barvaliya.m@icmr.gov.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harsha Hegde |
| Designation |
Scientist F |
| Affiliation |
ICMR National Institute of Traditional Medicine Belagavi |
| Address |
N210, 2nd floor, Block 1, Department of Ethnomedicine, ICMR National Institute of Traditional Medicine, Opp KLE campus, Nehrunagar
Belgaum
KARNATAKA
590010
India |
| Phone |
08312439220 |
| Fax |
|
| Email |
harshah@icmr.gov.in |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, V Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi 110029, India |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
Ansari Nagar New Delhi 110029 India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Milind Modak |
Deenanath Mangeshkar Hospital and Research Center |
Room No.- C Wing, Ground floor, Dept. of Ayurveda & Integrative Medicine and Dept. of Orthopedic Surgery, Mhatre Bridge,
Erandawane, Pune - 411004
Pune
MAHARASHTRA |
9371017638
drmilindmodak@gmail.com |
| Dr Sachin Kale |
DY Patil Deemed to be University School of Medicine |
OPD No. 22, Ground floor, Dept. of Orthopedics, Sector 5, Nerul, Navi Mumbai - 400706
Mumbai (Suburban)
MAHARASHTRA |
9821431687
sachinkale@gmail.com |
| Dr Aditya Pundkar |
Jawaharlal Nehru Medical College |
OPD No. D/002 B, Ground floor, Dept. of Orthopedics, DMIHER, Sawangi (Meghe), Wardha - 442107
Wardha
MAHARASHTRA |
9975170898
draditya.pundkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH,D.Y.PATIL SCHOOL OF MEDICINE, NAVI-MUMBAI |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE FOR BMHR |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE OF DMIHER |
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 | Other than Classical | | (1) Medicine Name: Gel containing 70% Plumbago zeylanica root powder, Reference: NA, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(mg), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 4 Weeks, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | 1% Diclofenac Gel | Application of 1% Diclofenac Gel (Standard) twice daily for 4 weeks |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients with age between 40-70 years
2. Clinically diagnosed and radiologically confirmed mild to moderate (KL grade II & III) symptomatic cases of OA of knee joints
3. Onset of symptom duration greater than or equal to 6 months at the time of screening
4. A score of greater than or equal to 9 on the 20-point Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain subscale at baseline
5. Greater than or equal to 5 score on 10-point visual analogue scale (VAS) for pain at baseline
6. Willing to give consent for participating in the study
|
|
| ExclusionCriteria |
| Details |
1. Patients having severe (KL grade IV) and disabling arthritis in targeted or contralateral knee joint
2. Patients with radiologically abnormal knee alignment
3. Those who are suffering from skin related problem at local sites of drug application which may affect drug application
4. Patients with history of HIV, Peripheral vascular diseases
5. Those who are on treatment with immuno-suppressive drugs and biologicals
6. Patients with history of Chikungunya, Dengue, or other viral infections in the past six months
7. Pregnant and lactating women
8. Any condition which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results
9. Diagnosed cases of Rheumatoid arthritis (RA factor positive) and Gouty arthritis (Serum Uric acid greater than UNL)
10. Patient requiring any systemic analgesic for other conditions which can affect the outcome of study drug
11. Patient on systemic corticosteroid therapy
12. Known case of history of allergy with NSAIDs or test drug
13. Patients with BMI greater than or equal to 35 kg/m2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in WOMAC score- Pain, WOMAC score- Stiffness, WOMAC- Functional Total |
Baseline/Screening
Week 1
Week 2
Week 3
Week 4
Week 6 (post intervention)
Week 8 (post intervention)
Week 12 (post intervention) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in range of motion (goniometry) |
Baseline/Screening
Week 1
Week 2
Week 3
Week 4
Week 12 (post intervention) |
| Changes in Quality of life at the end of intervention and at the end of post intervention as compared to baseline using Osteoarthritis Knee and Hip Quality of Life (OAKHQoL) questionnaire |
Baseline
Week 4
Week 12 (post intervention) |
| To determine extent of use of rescue medicines in the both the group during the study |
Week 1
Week 2
Week 3
Week 4
Week 6 (post intervention)
Week 8 (post intervention)
Week 12 (post intervention) |
|
|
Target Sample Size
|
Total Sample Size="292"
Sample Size from India="292"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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="2"
Months="6"
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
|
Patients visiting the orthopedic OPD of 3 selected hospitals, aged 40-70 years with clinically diagnosed and radiologically confirmed mild to moderate (KL grade II & III) symptomatic cases of osteoarthritis of knee joints will be subjected to detailed screening. Consecutive patients fulfilling the inclusion/exclusion criteria will be enrolled for the study after obtaining written informed consent, and randomly assigned to one of two groups in a 1:1 ratio using computer-generated random sequences. The intervention group will receive topical application of 70% P. zeylanica root gel twice daily for 4 weeks whereas, the control group will have topical application of diclofenac 1% gel twice daily for 4 weeks. Participants will be followed up weekly at week 1 (± 2 days), 2 (± 2 days), 3 (± 2 days), and 4 (± 2 days) and evaluated for WOMAC score, pain assessment by VAS score, measurement of range of motion using gonioscopy, drug compliance, need for rescue medicine, adverse reaction. Quality of life assessment will be done using Osteoarthritis Knee and Hip Quality of Life (OAKHQOL) assessment at baseline, week 4 and week 12.
Hypothesis - The test drug (gel containing Plumbago zeylanica L. root) improves the OA condition, in terms of WOMAC and pain scores and the quality of life in OA patients. |