| CTRI Number |
CTRI/2024/01/061360 [Registered on: 11/01/2024] Trial Registered Prospectively |
| Last Modified On: |
06/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Preventive
Screening
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Rheumatoid arthritis is a chronic inflammatory joint disease where the most commonly observed in old age in both gender. Homoeopathy has scope in Rheumatics arthritis which prevent the disease progress and decrease the severity of majority of RA symptom. . |
|
Scientific Title of Study
|
A Study to Assess the Effectiveness of Bryonia Alba in Treatment of Rheumatoid Arthritis in Comparison with Rhus Toxicodendron |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Santosh Reddy K Hudgikar |
| Designation |
Professor of Pharmacy Department |
| Affiliation |
Parul Institute of Homoeopathy and Research |
| Address |
Parul Institute of Homoeopathy and Research.
Parul University.
Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9663875835 |
| Fax |
|
| Email |
santoshaareddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Munjal Thakar |
| Designation |
Professor , Department of Homoeopathic materia medica |
| Affiliation |
Jawaharlal Nehru Homoeopathic medical collage. Parul university. Gujarat. |
| Address |
Jawaharlal Nehru Homoeopathic medical collage.
Parul university.
Gujarat.
Vadodara
GUJARAT
391760
India |
| Phone |
9227926514 |
| Fax |
|
| Email |
drmunjalthakar@drmunjalthakar.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Santosh Reddy K Hudgikar |
| Designation |
Professor of Pharmacy Department |
| Affiliation |
Parul Institute of homoeopathy and research |
| Address |
Parul Institute of Homoeopathy and Research.
Parul University.
Gujarat.
GUJARAT
391760
India |
| Phone |
9663875835 |
| Fax |
|
| Email |
santoshaareddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bryonia alba
30 potency
Rhus Tox 30 potency TID
every 15 day for 6 months
studiy will be done at Jawaharlal Nehru Homoeopathic medical collage Hospital, Limda, Parul university, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Santosh Reddy |
| Address |
Parul institute of Homoeopathy and Research , Hospital.
ishwarpura. Parul University |
| 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 Santosh Reddy |
Jawahar Lal Nehru homoeopathic medicine college and hospital |
Medicine opd,
Room NO 110
Jawahar Lal Nehru homoeopathic medicine college and hospital,parul University,linda, waghodia
Vadodara
GUJARAT |
9663875835
santoshaareddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Rheumatoid arthritis |
| Patients |
(1) ICD-10 Condition: M858||Other specified disorders of bonedensity and structure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bryonia Alba
30 Potency. TID |
Every 15 days for 6 months |
| Comparator Agent |
Rhus tox
30 potency TID |
every 15 days for 6 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Both gender
Age group 30-60 years
Diagnosed subjects of RA as per American College of Rheumatism- European League Against Rheumatism (ACR-EULAR) 2010 criteria Subjects willing to participate and sign the written informed consent form explained in their own language
|
|
| ExclusionCriteria |
| Details |
Rheumatoid arthritis with extra articular features
Rheumatoid arthritis with deformities
Pregnancy and Lactating mother
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| There may be significant difference between effectiveness of Bryonia alba and Rhus toxicodendron in the treatment of Rheumatoid arthritis among the age group 30-60years |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There may not be significant difference between effectiveness of Bryonia alba and Rhus toxcicodendron in the treatment of Rheumatoid arthritis among the age group 30-60years. |
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 2 |
|
Date of First Enrollment (India)
|
18/01/2024 |
| 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 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
|
Rheumatoid Arthritis is most common Joint disease observed in small joint in all ages and both sex which decreased the physical activity of person and hamper the physical and mental ability. Homoeopathic system of medicine which act on principle and law of nature with aim to reducing the frequency, duration and prevention of recurrence of disease and thus improve the mobility of joint , general well being of individual, in reducing the pain and disability. |