| CTRI Number |
CTRI/2023/08/056521 [Registered on: 16/08/2023] Trial Registered Prospectively |
| Last Modified On: |
14/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative clinical study of Rasnasaptak Kashaya Ghanvati and Rasnapanchak Kashaya Ghanvati in Rheumatoid Arthritis |
|
Scientific Title of Study
|
A comparative pharmaceutico analytical and clinical study of Rasnasaptak Kashaya And Rasnapanchak Kashaya Ghanvati in Amavata w.s.r.to 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 |
Dr Komal Sharma |
| Designation |
MD Scholar |
| Affiliation |
Post graduate training and research institute,Government Ayurvedic College Patiala Punjab |
| Address |
PG Department Of Rasa Shastra,Post graudate training and research institute,Government Ayurvedic College Patiala
Patiala
PUNJAB
147001
India |
| Phone |
9888672102 |
| Fax |
|
| Email |
komalbatish97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravneet Kaur Chahal |
| Designation |
Lecturer |
| Affiliation |
Post graduate training and research institute,Government Ayurvedic College Patiala Punjab |
| Address |
PG Department Of Rasa Shastra,Post graduate training and research institute,Government Ayurvedic College Patiala
Patiala
PUNJAB
147001
India |
| Phone |
8054336632 |
| Fax |
|
| Email |
ravneetkaur8989@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravneet Kaur Chahal |
| Designation |
Lecturer |
| Affiliation |
Post graduate training and research institute,Government Ayurvedic College Patiala Punjab |
| Address |
PG Department Of Rasa Shastra,Post graduate training and research institute,Government Ayurvedic College Patiala
PUNJAB
147001
India |
| Phone |
8054336632 |
| Fax |
|
| Email |
ravneetkaur8989@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College, Patiala, Punjab |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College Patiala |
| Address |
Government Ayurvedic College Patiala, ,Punjab, 147001 |
| 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 Komal Sharma |
Government Ayurvedic Hospital, Patiala |
Room No.1 Panchkarma building, Government Ayurvedic Hospital,Patiala
Patiala
PUNJAB |
9888672102
komalbatish97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, No,4678, Government Ayurvedic College Patiala Punjab |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M959||Acquired deformity of musculoskeletal system, unspecified. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Rasnasaptak Kashaya ghanvati, Reference: Sharanghdhar Samhita madhyam Khand Verse No. 2/89, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: -(2) Medicine Name: Rasnapanchak Kashaya Ghan vati, Reference: Sharanghdhar Samhita madhyam Khand Verse No. 2/87, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1000 Days, anupAna/sahapAna: Yes(details: lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient willing for trial
2. Either Sex will be selected
3. Newly Diagnosed case and patient not on any medication since one month will be selected
4. Patient having classical symptoms of Rheumatoid Arthritis will be Selected
|
|
| ExclusionCriteria |
| Details |
1. Age more than 70 yrs and less than 20 yrs.
2. Patient not willing for trial.
3. Pregnancy and lactating mothers
4. Patients suffering from any known case of severe systemic disorder like Crohn Disease, SLE, Graves disease, AIDS etc, which may interfere with the course of treatment will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective Parameter- Grading will be done with sign & symptoms of Amavata
RA factor,ESR,CRP,SGOT,SGPT,Uric Acid,HB,TLC to rule out other pathologies |
After one month intervention of Rasnasaptak kashaya Ghanvati and Rasnapanchak kashaya Ghanvati orally. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Subjective parameter-grading will be done with sign & symptoms of Amavata RA factor, ESR,CRP,SGOT,SGPT,Uric acid,HB |
After one mmonth intervention of Rasnasaptak Kashaya Ghanvati & Rasnapanchak Kashaya Ghanvati |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
26/08/2023 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
In this trial we are selecting patients of Amavata in two groups, in which we will do intervention study of study with Rasnasaptak kashaya ghanvati and Rasnapanchak kashaya ghanvati with the dose of two tablets of 500 mg BD assesment will be done on the subjective and objective parameters for the Amavata. Route of Drug Adminitration - Oral Follow up- Day 10, day 20, day 30 |