| CTRI Number |
CTRI/2026/03/105910 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [THERAPEUTIC] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Homoeopathic medicine in treatment of knee osteoarthritis |
|
Scientific Title of Study
|
Analytical characterization of Harpagophytum procumbens mother tincture and its effectiveness in comparison with individualized homoeopathic medicine in the management of knee osteoarthritis: An open- label 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 HARSHITA PAHWA |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
SECTOR A-8, CHAUDHARY RAMDEV CHOWK, NARELA, DELHI-110040
North West
DELHI
110040
India |
| Phone |
9968236336 |
| Fax |
|
| Email |
harshita.pahwa1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANKITA BHAKAT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
SECTOR A-8, CHAUDHARY RAMDEV CHOWK, NARELA, DELHI-110040
North West
DELHI
110040
India |
| Phone |
9475617024 |
| Fax |
|
| Email |
bhakatankita05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr RAJIB PURKAIT |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
NATIONAL INSTITUTE OF HOMOEOPATHY |
| Address |
SECTOR A-8, CHAUDHARY RAMDEV CHOWK, NARELA, DELHI-110040
North West
DELHI
110040
India |
| Phone |
9748925539 |
| Fax |
|
| Email |
drrajib.nih@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr HARSHITA PAHWA |
| Address |
NATIONAL INSTITUTE OF HOMOEOPATHY, SECTOR A-8, CHAUDHARY RAMDEV CHOWK, NARELA, DELHI
110040 |
| 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 HARSHITA PAHWA |
NATIONAL INSTITUTE OF HOMOEOPATHY |
HOMOEOPATHIC PHARMACY (OPD NO. 119 & 120), SECTOR A-8, CHAUDHARY RAMDEV CHOWK, NARELA, DELHI
110040
North West
DELHI |
9968236336
harshita.pahwa1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, NATIONAL INSTITUTE OF HOMOEOPATHY, DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HARPAGOPHYTUM
PROCUMBENS |
Mother tincture procured from GMP certified company will be administered orally 20 drops twice per day for 3 months. |
| Comparator Agent |
INDIVIDUALISED HOMOEPATHIC MEDICINE |
Individualised Homoeopathic Medicine prescribed according to homoeopathic principle. All the medicine will be administered orally, procured from GMP certified company. Potency, dose and repetition will be as per the homoeopathic principles or as per the need. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All religion and all socio-economic status
2. Diagnosis will be done by using American College of Rheumatology (ACR) criteria including Knee X-Ray
3. Grade I and II knee osteoarthritis as per Kellgren–Lawrence Grading Scale.
4. Participant who are willing to give written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Advanced and complicated cases of osteoarthritis requiring surgical intervention.
2. Participants with other complicated joint disorder (seronegative arthropathies, RA, Gout
etc.) which interfere with the evaluation of OA.
3. Adults who had a history of heart attack or stroke, or other atherosclerotic disease.
4. Uncontrolled systemic diseases like HTN, DM, Hypothyroidism etc.
5. Pregnant and lactating women
6. Psychologically ill patients
7. Immunocompromised patients
8. Participants undergoing homoeopathic treatment for any other chronic disease for last 6 months.
9. Simultaneous participation in any other clinical trial. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score. |
Assessed at baseline and after 3-months of intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Knee X- Ray
|
Assessed at baseline and after 3-months of intervention.
|
| Modified Naranjo Criteria for Homeopathy (MONARCH) clinical assessment. |
Assessed after 3-months of intervention. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 |
|
Date of First Enrollment (India)
|
22/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
22/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Osteoarthritis (OA) is recognized as a complex condition involving changes in the underlying bone, chronic inflammation of the synovium, immune responses, and even neuroinflammation that contribute to pain and joint damage. This study aims to fill the existing research gap and contribute to the evidence base for Homoeopathic management of knee osteoarthritis Therefore, randomized controlled trial will be conducted at the OPD of NIH, Delhi to compare the effectiveness of individualized homoeopathic treatment with Harpagophytum procumbens in patients with knee osteoarthritis. Analytical characterization of Harphagophytum procumbens will be done followed by clinical study. Through randomisation two groups will be allotted, in which Group A, Harpagophytum procumbens mother tincture will be administered 20 drops twice per day for 3 months which is safe as per the published literature and in Group B, Individualised Homoeopathic medicine will be prescribed according to homoeopathic principle. All participants will be followed up at 2-week intervals for a minimum of 12 weeks. Outcome will be assessed at baseline and after 3 months of intervention. All the cases will be analyzed with WOMAC Index Score and Knee X-Ray after 3 months of intervention. At each visit, clinical progress will be documented, and adverse events (if any) or complications will be noted, and measure will be taken accordingly. Lastly MONARCH score will be evaluated at the end of treatment. Duration of therapy will be of 3 months. |