| CTRI Number |
CTRI/2024/10/074536 [Registered on: 01/10/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reducing Rheumatoid Arthritis symptoms with Mustadi ghan vati |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF MUSTADI GHANVATI IN
AMAVATA (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 |
Diksha Thakur |
| Designation |
P.G. Scholar |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital Roorkee |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
8557076393 |
| Fax |
|
| Email |
dikshathakur1881@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajnikant Rohila |
| Designation |
Professor |
| Affiliation |
Quadra Institute Of Ayurveda and Hospital NH58 Roorkee - Haridwar road near montfort school Roorkee |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
8557076393 |
| Fax |
|
| Email |
drrajnikant83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Diksha Thakur |
| Designation |
P.g. Scholar |
| Affiliation |
Quadra Institute Of Ayurveda And Hospital Roorkee |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar road Near Montfort School Roorkee 247667
Hardwar
UTTARANCHAL
247667
India |
| Phone |
08557076393 |
| Fax |
|
| Email |
dikshathakur1881@gmail.com |
|
|
Source of Monetary or Material Support
|
| DIKSHA THAKUR opd no 2 DEPARTMENT OF P.G. KAYACHIKITSA QUADRA INSTITUTE OF AYURVEDA AND HOSPITAL Nh 58 ROORKEE - Haridwar road near montfort school , Roorkee (Haridwar) India 247667 |
|
|
Primary Sponsor
|
| Name |
Diksha Thakur |
| Address |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar Road Near Montfort School Roorkee (Haridwar ) India 247667 |
| Type of Sponsor |
Other [Self] |
|
|
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 Diksha Thakur |
Quadra Institute Of Ayurveda And Hospital |
Opd No 2 Department Of Kayachikitsa Quadra Institute Of Ayurveda And Hospital Nh 58 Roorkee Haridwar road near Montfort School Roorkee ( Haridwar) India 247667
Hardwar
UTTARANCHAL |
08557076393
dikshathakur1881@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE QUADRA INSTITUTE OF AYURVEDA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M069||Rheumatoid arthritis, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: MUSTADI GHAN VATI , Reference: CHARAK SAMHITA SUTRA STHANA ADHAYA 23 SALOK NO 13-14, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -LUKEWARM WATER ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing to participate in the trial and sign the consent form.
2. Patients of Rheumatoid arthritis with features mentioned in subjective parameters.
3. The patients between the age group of 20 to 50 years of age.
4. Patients having classical features of Amavata like Angamarda, Aruchi,Trishna,
Hrillasa, Alasya, Gaurava, Jwara, Shoola, Shotha.
5..Patients must fulfill the criteria for rheumatoid arthritis outlined by the 2010 ACR
(American College of Rheumatology) and EULAR (European League Against Rheumatism). |
|
| ExclusionCriteria |
| Details |
1.Patient not willing for trial.
2. Patient below the age of 20 years and above 50 years.
3.Patients having Severe crippling bone deformity
4.Patients having another type of arthropathy such as Gout, Ankylosing spondylitis etc.
5. Juvenile rheumatoid arthritis, Severely deformed joints, with genetic and endocrinal
disorder, or any other chronic illness.
6. Patients taking antibiotic therapy for any systemic illness within 2 months, Pregnant
women and lactating mother.
7. Any other patient considered unfit for inclusion in trial after investigation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
RELIEF IN SUBJECTIVE PARAMETERS :-
1.PAIN
2.SWELLING
3.STIFFNESS
4.TENDERNESS
5.GENERAL SYMPTOMS |
First follow up- after 15 days of first trial
Second follow up - 15 days after first follow up.
Third follow up- 15 days after second follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
RELIEF IN OBJECTIVE PARAMETERS :-
1.JOINT INVOLVEMENT
2.SEROLOGY (RA FACTOR )
3.ACUTE PHASE REACTANT |
ASSESSMENT WILL BE DONE ON 0 DAY AND 45 DAYS . |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
14/10/2024 |
| 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="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
Modification(s)
|
THIS IS AN OPEN LABEL CLINICAL STUDY TO EVALUATE THE EFFECT OF MUSTADI GHANVATI IN AMAVATA (RHEUMATOID ARTHRITIS). It will be a clinical study of 30 patients suffering from rheumatoid arthritis. Patient will be randomly selected irrespective of their gender, race, religion, occupation.-Patient with classical features of Amavata attending the OPD and IPD of Kayachikitsa department of Quadra institute of Ayurveda,Roorkee will be selected for this clinical study.The patients between the age group of 20 to 50 years of age.The assessment of the trial will be done on the basis of subjective and objective parameters .The period of study is 18 months and duration of study is 45 days . Data depending upon above subjective and objective criteria and other variables will be collected and analyzed statistically. |