| CTRI Number |
CTRI/2025/06/088016 [Registered on: 02/06/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to find out if Homoeopathy With and Without Chelidonium can help reduce joint pain and stiffness |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the role of individualised homoeopathic remedy with and without Chelidonium Q in the management of Osteoarthritis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Charumathy Sashi Kumar |
| Designation |
UG Scholar (Intern) |
| Affiliation |
Venakateswara Homoeopathic Medical College and Hospital |
| Address |
4/11 samayapuram main road, Karambakkam, porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
7010083160 |
| Fax |
|
| Email |
drcharusashi29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sandhya |
| Designation |
Professor |
| Affiliation |
Venkateswara Homoeopathic Medical College and Hospital |
| Address |
Department of Community Medicine,
4/11, Samayapuram Main Road,
karambakkam, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841002329 |
| Fax |
|
| Email |
drsandhyakalidas@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sandhya |
| Designation |
Professor |
| Affiliation |
Venkateswara Homoeopathic Medical College and Hospital |
| Address |
Department of Community medicine, 4/11, Samayapuram main Road, Karambakkam, Porur, Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841002329 |
| Fax |
|
| Email |
drsandhyakalidas@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Venkateswara Homoeopathic Medical College and Hospital, Department of Community Medicine, 4/11 Samayapuram Main Road, karambakkam , Porur, Chennai 600116 Tamil Nadu, India |
|
|
Primary Sponsor
|
| Name |
Venkateswara Homoeopathic Medical College and Hospital , Chennai |
| Address |
4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai- 600116 Tamil Nadu, India |
| Type of Sponsor |
Private 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 S SANDHYA |
Venkateswara Homeopathic Medical College and Hospital |
Unit(Room) -4,
4/11, Samayapuram Main Road, Karambakkam, Porur, Chennai 600116, Tamil Nadu, India
Chennai
TAMIL NADU |
9841002329
drsandhyakalidas@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Venkateswara Homoeopathic Medical College and Hospital Institutional Ethics Committee for Human Research |
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 |
Individualised Homoeopathic Remedy with Chelidonium majus Q |
As per the Homoeopathic principles of Posology dosage and frequency of repetition of the indicated remedy will be prescribed as per the requirement of each case. The medicine will be administered orally as 4 pills twice daily 15 minutes before food for a period of 12 weeks. Chelidonium majus Q shall be administered as 15 drops twice daily in quarter glass of water 15 minutes after food for a period of 12 weeks |
| Comparator Agent |
Individualised Remedy without Chelidonium majus Q |
As per the Homoeopathic principles of Posology dosage and frequency of repetition of the indicated remedy will be prescribed as per the requirement of each case. The medicine will be administered orally as 4 pills twice daily 15 minutes before food for a period of 12 weeks. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
patients diagnosed with Osteoarthritis of Knee with Western Ontario McMaster Universities Arthritis Index score of more than 40. Patients with Visual Analogue Scale of more than 4 |
|
| ExclusionCriteria |
| Details |
Rheumatoid arthritis, psoriatic arthritis, Gout. patients with any other disease affecting mobility, patients with severe systemic illness such as liver and kidney dysfunction, diabetes, cardio vascular disease, patients on long term NSAIDS or steroids, |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| WOMAC score |
Baseline and after 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Score, joint stiffness and physical functions of the patient |
baseline ,2weeks, 4 weeks, 6 weeks,8weeks, 10 weeks, 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
10/06/2025 |
| 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)
|
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
|
Background: Osteoarthritis (OA) is a long-term joint condition that
causes pain, stiffness, and reduced mobility, often affecting a person’s daily
life. Homoeopathy offers a gentle, holistic approach to managing such chronic
conditions. Chelidonium Majus Q, a well-known homoeopathic mother tincture, has
traditionally been used to address hepatic disorders, this study explores how
effective Chelidonium Majus Q when given along with individualized Homoeopathic
medicine in review with Homoeopathic Materia medica is in relieving the
symptoms of Osteoarthritis of the knee.
Objective: This study is intended to determine and evaluate the
effectiveness of Chelidonium Majus in mother tincture form in reduction of pain
and stiffness in patients with Osteoarthritis, and to compare the WOMAC scores and Visual Analogue Scale of both groups to determine statistical significance.
Methodology: This Randomized clinical study of 60 cases involving two
groups, 30 cases each. GROUP 1 cases managed with individualized homoeopathic
medicine and Chelidonium majus Q, GROUP 2 cases managed with individualized
homoeopathic medicine only. The results obtained will be statistically
analyzed and evaluated by using Paired âTâ test in order to determine the
effectiveness of Chelidonium majus Q in symptomatic relief of Osteoarthritis of
the knee. This study provides evidence to say that, Chelidonium majus in the
form of mother tincture have significant results in lowering the pain and joint
stiffness, and improves the mobility of the affected knee in Osteoarthritis
patients.
Expected Outcome: This study anticipates demonstrating that Patients
administered with Chelidonium majus q along with Individualized homoeopathic
medicine will show significant reduction in pain and stiffness of joint, which is assessed through WOMAC scale and Visual Analogue Scale |