| CTRI Number |
CTRI/2026/03/106468 [Registered on: 18/03/2026] Trial Registered Prospectively |
| Last Modified On: |
18/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effectiveness of Angustura vera in the management of Knee Osteoarthritis |
|
Scientific Title of Study
|
To study the effectiveness of Angustura vera in Knee Osteoarthritis using Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index: Single arm, interventional study |
| 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 Aarti Sharma |
| Designation |
Postgraduate trainee |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No. 109, 1st Floor, Department of Materia Medica, Sector A8 Chaudhary Ramdev Chowk Narela Delhi India
North
DELHI
110040
India |
| Phone |
8076667597 |
| Fax |
|
| Email |
sharma1407aarti@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shruti Jain Vij |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No. 109, 1st Floor, Department of Materia Medica, Sector A8 Chaudhary Ramdev Chowk Narela Delhi India
North
DELHI
110040
India |
| Phone |
8527085598 |
| Fax |
|
| Email |
drshrutijainvij@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shruti Jain Vij |
| Designation |
Assistant Professor |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD No. 109, 1st Floor, Department of Materia Medica, Sector A8 Chaudhary Ramdev Chowk Narela Delhi India
North
DELHI
110040
India |
| Phone |
8527085598 |
| Fax |
|
| Email |
drshrutijainvij@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Homoeopathy Sector A8 Chaudhary Ramdev Chowk Narela Delhi India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Sector A8 Chaudhary Ramdev Chowk Narela Delhi India |
| Type of Sponsor |
Government medical college |
|
|
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 Aarti Sharma |
National Institute of Homoeopathy |
OPD No. 109, 1st Floor, Department of Materia Medica, Sector A8 Chaudhary Ramdev Chowk Narela Delhi India
North
DELHI |
8076667597
sharma1407aarti@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethical Committee of National Institute of Homoeopathy Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M17||Osteoarthritis of knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Angustura vera |
Angustura vera will be given to all specifically indicated cases based on the susceptibility, twice daily for 3 days. Follow up will be done at every 15 days for a period of 4 months and the next potency, dose, repetition will be done according to the sign and symptoms of improvement. WOMAC scoring will be compared at baseline and after 4 months of intervention to assess changes in pain, stiffness, and functional limitation. The medicine will be dispensed from NIH, Delhi which is procured from GMP certified manufacturer. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Cases of primary knee osteoarthritis.
2. Patients diagnosed under ACR Diagnostic Guidelines for Osteoarthritis of knee.
3. Radiologically confirmed cases of knee Osteoarthritis (Kellgren–Lawrence Grade I–III).
4. Patients who have already had other method of treatment but now intend to undergo homoeopathic treatment, after providing a gap of two weeks as wash-out period.
5. Baseline WOMAC score indicating mild (25-41) to moderate symptoms (42-69).
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating women.
2. Patients with Psychiatric disorders and drug addiction.
3. Presence of unstable or serious medical illnesses such as uncontrolled diabetes, thyroid disease, cardiovascular disease, hepatic or renal failure, neurological disorders that may interfere with treatment or assessment.
4. Patients who continue to be under other method of treatment.
5. Patients not willing to undergo any investigation, if so advised.
6. Patient who may discontinue their treatment.
7. Patient who are intermittently taking other method of treatment during the homoeopathic treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the WOMAC scores at baseline and after 4 months of intervention to assess changes in pain, stiffness, and functional limitation. |
At baseline and after 4 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the causal relationship between the intervention and clinical outcome using MONARCH criteria. |
When improvement begins till 4 months of intervention |
| To assess the adverse drug reactions reported during study. |
At every 15 days post-intervention till 4 months. |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Knee osteoarthritis (ICD-11: FA01.0) is the most common form of Osteoarthritis worldwide and is associated with significant morbidity, disability, and reduced quality of life, particularly among the ageing population. Angustura vera (Galipea officinalis), prepared from the bark of a tree of the Rutaceae family native to Colombia and Venezuela, is a lesser-used homoeopathic medicine. It was first proved by Samuel Hahnemann and later described by Timothy Field Allen in the Materia Medica. Homoeopathic literature mentions its action on joints and bones, particularly in knee Osteoarthritis, with symptoms such as joint pain, stiffness after rest, and difficulty in walking. However, due to limited clinical studies with small sample sizes, clear evidence regarding its effectiveness is lacking.The present study aims to evaluate the effectiveness of Angustura vera in patients with knee Osteoarthritis. The objective of the study is to compare the changes in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score at baseline and after 4 months of treatment with Angustura vera in patients with knee Osteoarthritis.The results of this study are expected to support wider and more confident use of this medicine by homoeopathic practitioners in their routine clinical practice. |