| CTRI Number |
CTRI/2024/02/062213 [Registered on: 01/02/2024] Trial Registered Prospectively |
| Last Modified On: |
04/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Homoeopathic Medicine Formica rufa in gout |
|
Scientific Title of Study
|
A clinical comparitive study to find the efficacy of Formica rufa 6CH and 30CH potencies in the treatment of gout |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANDALAMALA NAGA SRI |
| Designation |
PG SCHOLAR |
| Affiliation |
Vinayaka Missions Homoeopathic Medical College and Hospital |
| Address |
Room NO 3d1, Medical unit IV PG Department of Practice of Medicine, Ground floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari Main Road,Seeragapadi PO Salem
Salem
TAMIL NADU
636308
India |
| Phone |
8639055015 |
| Fax |
|
| Email |
andalamalanagasri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VenkatesanH |
| Designation |
Professor, head of the department and PG Guide |
| Affiliation |
vinayaka missions homoeopathic medical college and hospital |
| Address |
Room NO 3d1, Medical unit IV PG Department of Practice of Medicine, Ground floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari Main Road,Seeragapadi PO Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VenkatesanH |
| Designation |
Professor, head of the department and PG Guide |
| Affiliation |
vinayaka missions homoeopathic medical college and hospital |
| Address |
Room NO 3d1, Medical unit IV PG Department of Practice of Medicine, Ground floor, OPD Block, Vinayaka Missions Homoeopathic Medical College and Hospital, NH47, Sankari Main Road,Seeragapadi PO Salem
Salem
TAMIL NADU
636308
India |
| Phone |
9865134561 |
| Fax |
|
| Email |
venkathompath@gmail.com |
|
|
Source of Monetary or Material Support
|
| vinanaya mission homoeopathic medical college and hospital NH 47, sankari main road, seeragapadi po, salem, tamil nadu- 636308 |
|
|
Primary Sponsor
|
| Name |
VINAYAKA MISSION HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Address |
NH47, Sankari Main road, Seeragapadi PO, Salem, Tamil nadu-636308 |
| 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 Andalamala Naga sri |
VINAYKA MISSIONS HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
ROOM No 3d1, Medical Unit IV, PG Department of Practice of
Medicine, Ground Floor, OPD Block, Vinayaka Missions
Homoeopathic Medical College and Hospital ,NH 47,Sankari Main Road, Seeragapadi PO,
Salem TAMIL NADU 636308
India
Salem
TAMIL NADU |
8639055015
andalamalanagasri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Vinayaka Missions Kirupananda Variyar Medical College And Hosppital Salem |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M109||Gout, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Formica rufa 30 CH |
5 Medicated Globules of 30 Size Pills will be Prescribed Orally in Morning before food Weekly once to each Patient for 6 months |
| Intervention |
Formica rufa 6CH |
5 Medicated Globules of 30 Size Pills will be Prescribed Orally in Morning before food Weekly once to each Patient for 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
clinically diagnosed gout patients |
|
| ExclusionCriteria |
| Details |
gouty complications like joint deformity and bone loss
Pregnant females and lactating mothers |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in serum uric levels |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in score levels of gout assessment questionnaire (GAQ2.0) |
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| Date of Study Completion (India) |
19/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Gout, a result of hyperuricemia is a common disorder that affects patients of all ages and genders. Hyperuricemia is an elevated uric acid level in the blood. In homoeopathy many studies have contributed for the effectiveness of homoeopathic management in gout treated with different homoeopathic medicines. among those remedies formica rufa is less explores remedy. A homoeopathic case study has shown the effectiveness of formica rufa on gouty patients. The homoeopathic action of this medicine on gout is well established. yet no scientific studies have been conducted and reported on it. The incidence of gout is increasing day by day. Here, we would like to do a clinical comparative study of formica rufa 6 CH and 30 CH to know which potency is effective in treating gout. |