| CTRI Number |
CTRI/2024/10/075639 [Registered on: 22/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study of swelling reducing property of Homoeopathic medicine TINOSPORA CORDIFOLIA under laboratory setting with clinical study of the same in Arthropathy patients. |
|
Scientific Title of Study
|
In Vitro Study of anti-inflammatory activity of Homoeopathic medicine TINOSPORA CORDIFOLIA and clinical verification in Rheumatoid Arthritis patients-A Randomized controlled 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 Adhith T G |
| Designation |
Post Graduate Scholar |
| Affiliation |
PG Graduate Scholar |
| Address |
Department of Homoeopathic Repertory & Case taking Government Homoeopathic Medical College Karaparamba Kozhikode
Kerala
India
Kozhikode
KERALA
673010
India |
| Phone |
7561087422 |
| Fax |
|
| Email |
adhitg010@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya C |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Homoeopathic Repertory & Case taking Government Homoeopathic Medical College Karaparamba Kozhikode
Kerala
India
Kozhikode
KERALA
673100
India |
| Phone |
9446529775 |
| Fax |
|
| Email |
drjayakishan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya C |
| Designation |
Guide |
| Affiliation |
Government Homoeopathic Medical College Kozhikode |
| Address |
Department of Homoeopathic Repertory & Case taking Government Homoeopathic Medical College Karaparamba Kozhikode
Kerala
India
Kozhikode
KERALA
673100
India |
| Phone |
9446529775 |
| Fax |
|
| Email |
drjayakishan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Homoeopathic Medical College Karaparamba Kozhikode
Kerala
India
673010 |
|
|
Primary Sponsor
|
| Name |
Dr Adhith T G |
| Address |
Post Graduate Scholar Department Government Homoeopathic Medical College,Karaparamba,Kozhikode,Kerala 673010 |
| Type of Sponsor |
Other [NIL] |
|
|
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 Adhith T G |
Government Homoeopathic Medical College |
Research OP
Department OP Room Number 9 Government Homoeopathic Medical College Karaparamba p.o. Kozhikode
Kozhikode
KERALA |
7561087422
adhitg010@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Homoeopathic Medical College , Kozhikode, Kerala. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M056||Rheumatoid arthritis with involvement of other organs and systems, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
HOMOEOPATHIC MEDICINE |
Individualised Homoeopathic Medicine mentioned in HPI will be administered orally according to principles of Homoeopathy for 12 weeks |
| Intervention |
TINOSPORA CORDIFOLIA |
TINOSPORA CORDIFOLIA will be given in 40 size globules 4 globules twice a day for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Those patients satisfying 2010 ACR/EULAR criteria for Rheumatoid Arthritis
2.Subjects belonging to both sexes
3.Patients belonging to the age group 20-70 years |
|
| ExclusionCriteria |
| Details |
1.Cases associated with malignancies, renal failure, hepatic failure.
2.Pregnant females
3.Cases with disease activity score 28 more than 7.5(high disease activity) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Study Title:To assess anti-inflammatory activity.
Description:By assessing Percentage of inhibition
Interval:48 hours
2)Clinical study
Title:To assess the reduction in Disease Activity Score 28
Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value
Interval:3months
|
1)Study Title:To assess anti-inflammatory activity.
Description:By assessing Percentage of inhibition
Interval:48 hours
2)Clinical study
Title:To assess the reduction in Disease Activity Score 28
Description:Disease Activity Score 28 final value - Disease Activity Score 28 initial value
Interval:3months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of Therapeutic effectiveness of Homoeopathic medicine Tinospora cordifolia & Homoeopathic constitutional medicines among the group |
After 1 year(after completion of the study) |
|
|
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 3 |
|
Date of First Enrollment (India)
|
30/10/2024 |
| 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)
|
Open to Recruitment |
| 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
|
This consist of two parts. First part contain in vitro study of anti-inflammatory effect of Tinospora Cordifolia in Rheumatoid Arthritis blood sample collected from Inbiotics (ISO13485:2016) research laboratory, Nagercoil. And the second part consist of an in vivo Clinical evaluation anti-inflammatory effect of Tinospora Cordifolia in Rheumatoid Arthritis patients - A randomized controlled clinical trial. One group will be given by Homoeopathic medicine Tinospora Cordifolia and the other group will receive Homoeopathic constitutional medicine by randomization .Diagnosis of the case will based on ACR/EULAR criteria for Rheumatoid Arthritis and the evaluation of the study will be based on the estimation of Disease Activity Score 28 before and after the study . Each case will be evaluated for 3 months .Obtained values will be taken for analysis. Outcome will be measured by the reduction in Disease Activity Score 28 in all cases .
|