| CTRI Number |
CTRI/2025/10/095730 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Homoeopathic Medicines – Ammonium Phosphoricum and Formica Rufa – for Relief in Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Comparitive Study To Assess The Effectiveness Of Homoeopathic Medicine Ammonium Phosphoricum And Formica Rufa In The Management Of Cases Of Rheumatoid Arthritis |
| 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 Vikash Yadav |
| Designation |
Pg Scholar |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Practice of Medicine OPD no 1 Dr MPK Homoeopathic Medical College
Hospital and Research Centre A constituent college of Homoeopathy
Jaipur
RAJASTHAN
302029
India |
| Phone |
9602098414 |
| Fax |
|
| Email |
drvikashyadav1879@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Yadav |
| Designation |
Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Practice of Medicine OPD no 1 Dr MPK Homoeopathic medical college hospital and research center
Plot No 10 11 12 Village Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829053664 |
| Fax |
|
| Email |
PMpg2724dept@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok Yadav |
| Designation |
Professor |
| Affiliation |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
Department of Practice of Medicine OPD no 1 Dr MPK Homoeopathic medical college hospital and research center
Plot No 10 11 12 Village Saipura Sanganer Jaipur
Jaipur
RAJASTHAN
302029
India |
| Phone |
9829053664 |
| Fax |
|
| Email |
PMpg2724dept@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Practice of Medicine Dr Girendra Pal Homoeopathic Hospital and Research Centre Collegiate Hospital of Dr MPK Homoeopathic Medical College Hospital And Research Centre A constituent College of Homoeopathic University Saipura Sanganer Jaipur Rajasthan 302029 |
|
|
Primary Sponsor
|
| Name |
Dr MPK Homoeopathic Medical College Hospital and Research Centre |
| Address |
10 11 12 Ward no 36 Saipura Sanganer Jaipur Rajasthan 302029 |
| 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 Vikash Yadav |
Dr Girendra Pal Homoeopathic Hospital And Research Centre |
Department of Practice of Medicine, OPD no.1 Dr MPK Homoeopathic Medical College
Hospital and Research Centre A constituent college of Homoeopathy
Jaipur
RAJASTHAN |
09602098414
drvikashyadav1879@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee homoeopathy university jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ammonium Phosphoricum |
Ammonium Phosphoricum shall be given in any potency of 6C, 30CH, 200CH, 1M, 10M, and CM as per the case and Hahnemannian guidelines in the form of globules of 40 number, dose and repetition as per need of the case reassessment at the end of 3 month |
| Intervention |
Formica Rufa |
Formica Rufa shall be given in any potency of 6C, 30CH, 200CH, 1M, 10M, and CM as per the case and Hahnemannian guidelines in the form of globules of 40 number, dose and repetition as per need of the case reassessment at the end of 3 month |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed patients of Rheumatoid Arthritis. Previously diagnosed cases of Rheumatoid arthritis reoccurring, despite other medicines with no avail.
Patients having CRP variations.
Patients giving consent and maintaining follow up. |
|
| ExclusionCriteria |
| Details |
Immuno-compromised patients such as those suffering from HIV, Hepatitis B/C, etc.
Pregnant women and lactating mothers will not be included in the study.
Cases with multi-systemic illness will be excluded from the study, and cases with advanced pathology.
Patients who are not willing to give informed consent.
Taking other treatments for RA.
Patients having extra-articular manifestations
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement according to scores obtained(pre and post treatment) from the Visual Analogue scale(VAS score) |
Pre scores will be taken at baseline of treatment and post scores will be assessed at the end of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Symptomatic improvement in RA patients using homoeopathic medicine and changes in relevant clinical parameters (pain score, joint mobility, ESR, CRP,etc.) will be observed. |
12 months |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| 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) |
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
|
Aim : To evaluate and compare the effectiveness
of Ammonium Phosphoricum and
Formica Rufa in the management of Rheumatoid Arthritis. Objective: To
assess symptomatic improvement
in RA patients using homoeopathic
medicine.
To compare the effectiveness of Ammonium Phosphoricum and Formica Rufa. To observe changes
in relevant clinical
parameters (pain score, joint mobility, ESR, CRP, etc). To study the improvement in quality of life using a validated
scale (e.g., HAQ-DI). To compare which one is more effective
in Rheumatoid Arthritis. |