| CTRI Number |
CTRI/2024/05/067928 [Registered on: 27/05/2024] Trial Registered Prospectively |
| Last Modified On: |
20/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Relieving pain of Rheumatoid Arthritis by Curcuma longa mother tincture |
|
Scientific Title of Study
|
Clinical effectiveness of curcuma longa mother tincture in relieving pain of Rheumatoid Arthritis: A single arm clinical trial |
| 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 Sanjay Kumar singh |
| Designation |
Assistant Professor |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical college and Hospital |
| Address |
Department of Organon of medicine , Academic block , R.B.T.S. Govt. Homoeopathic Medical college and Hospital, Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
9304078805 |
| Fax |
|
| Email |
Sanjaydr1981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sambit Kumar Nayak |
| Designation |
Post Graduate Trainee |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical college Hospital |
| Address |
Department of Organon of medicine , Academic block , R.B.T.S. Govt. Homoeopathic Medical college Hospital Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
7854090438 |
| Fax |
|
| Email |
Sambitnayak123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jiya Kumari |
| Designation |
Post Graduate Trainee |
| Affiliation |
R.B.T.S. Govt. Homoeopathic Medical college Hospital |
| Address |
Department of Organon of medicine , Academic block , R.B.T.S. Govt. Homoeopathic Medical college Hospital Muzaffarpur
Muzaffarpur
BIHAR
842002
India |
| Phone |
8434725587 |
| Fax |
|
| Email |
jiya23kumari@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.B.T.S. Govt. Homoeopathic Medical college Hospital , Muzaffarpur ,Bihar ,842002 |
|
|
Primary Sponsor
|
| Name |
R.B.T.S. Govt. Homoeopathic Medical college Hospital |
| Address |
Ramdaylu Nagar , Post Ramna , Muzaffarpur 842002 |
| 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 Puja Kumari |
R.B.T.S. Govt. Homoeo. Medical College & Hospital |
OPD 1(Department of Medicine),OPD 4(Department of Surgery),OPD 5(Department of Practice OF Medicine), OPD 5(Department of Materia Medica)
Muzaffarpur
BIHAR |
9525748322
pujaarya062@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee ,R.B.T.S. Govt. Homoeo. Medical College & Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Curcuma Longa |
Medicine will be given as mother tincture in 15 ml bottle & follow up should be done in 15 days. The dose will be as 10 drops twice a day with one teaspoonful normal water. The route of administration is by Mouth |
| Comparator Agent |
Nil |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
i. 30-80 Age group
ii. Self reported & pre-diagnosed cases of RA.
iii. Patients with symptomatology of RA.
iv. Both sexes.
v. Patients volunteering
|
|
| ExclusionCriteria |
| Details |
i. Patients unwilling to take part or not giving consent to join the study.
ii. Diagnosed cases of systemic diseases, psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure.
iii. Substance abuse and/ or dependence.
iv. Self reported immune-compromised state.
v. Undergoing homoeopathic treatment for any chronic disease within the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of pain by Universal pain assessment scale before and after intervening with Curcuma Longa mother tincture |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess quality of life of Rheumatoid Arthritis patients 36-Item Short-Form Health Survey (SF-36). |
3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
31/05/2024 |
| 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="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
|
Rheumatoid arthritis (RA) is a common form of inflammatory arthritis, occurring throughout the world and in all ethnic groups. The prevalence of RA is approximately 0.8-1.0% in Europe and the Indian subcontinent, with a female-to-male ratio of 3: 1. Curcuma Longa otherwise named as Turmeric has been long used in both Ayurvedic and Chinese medicine as an anti inflammatory , to treat digestive disorders and liver problems and for the treatment of skin disease. Curcuma longa has analgesic property has been confirmed in relieving various types of pains like toothache, abdominal colic and joint pain. With this intention, we plan to test the effectiveness of Curcuma longa Mother Tincture in patients of RA. |