| CTRI Number |
CTRI/2022/10/046617 [Registered on: 19/10/2022] Trial Registered Prospectively |
| Last Modified On: |
06/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
To know tha effect of churan and kwatha in tha management of Amavata w.s.r. to Rheumatoid Arthritis |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the effect of Pathyadi churan and Shunthyadi kwatha in the management of Amavata w.s.r. to Rheumatoid Arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Thakur |
| Designation |
MD (Ayu) Reader kayachikitsa department |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic college paprola |
| Address |
Department of kayachikitsa room number 220 Rajiv Gandhi Govt Post Graduate Ayurvedic college Kangra HIMACHAL PRADESH 176115 INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Thakur |
| Designation |
MD (Ayu) Reader kayachikitsa department |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic college paprola |
| Address |
Department of kayachikitsa room number 220 Rajiv Gandhi Govt Post Graduate Ayurvedic college Kangra HIMACHAL PRADESH 176115 INDIA
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
9816195001 |
| Fax |
|
| Email |
dr.skumarthakur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Navjot singh |
| Designation |
PG Scholar |
| Affiliation |
Rajiv Gandhi Govt Post Graduate Ayurvedic College Paprola |
| Address |
Kayachikitsa Department Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola
Kangra
HIMACHAL PRADESH
176115
India |
| Phone |
7973312693 |
| Fax |
|
| Email |
drnavjot721996@gmail.com |
|
|
Source of Monetary or Material Support
|
| Baijnath Pharmacy Paprola District kangra Himachal Pradesh |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
| Address |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola District kangra Pin Code 176115 |
| 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 Sunil Thakur |
Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola |
Kayachikitsa Department room no. 220 Rajiv Gandhi Govt Post Graduate Ayurvedic College and Hospital Paprola District kangra Pin Code 176115
Kangra
HIMACHAL PRADESH |
9816195001
dr.skumarthakur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (HUMAN) |
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. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Pathyadi churan , Reference: chakardutt Aamvatadhikar /44, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -lukewarm water ), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi kwatha , Reference: chakardutt Aamvatadhikar/9 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 25(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -equal amount of watar ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for study.
Patients in the age group between 30-70 years, irrespective of sex and socio-economic status.
Patient with signs and symptoms of Amavata w.s.r. to Rheumatoid Arthritis as described in texts and fulfill the diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
Patients not willing for the trial
Patients with age group below 30 and above 70 years.
Allergy to the trial drug.
Patients having any type of arthopathy such as neoplasm of spine,ankylosing spondylosis, osteoarthritis, traumatic arthritis and pyogenic osteomyelitis etc. Patients suffering from chronic renal, respiratory, cardiac and hepatic . disorder.
Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief in symptoms of Amavata after intervention of pathyadi churana and shunthayadi kwatha
Angamarda
Aruchi
Trishna
Alsaya
Apaka
Gaurava
Jwara
Sandhishoola
Sandhishotha
Sparshasahtva
Vibandha
Antrakujana
Nidraviparyaya
Praseka Daha |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improving quality of life |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
30/10/2022 |
| 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="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
patients will be selected from faculty/OPD of RGGPG Ayurvedic College and Hospital, Paprola. Two groups of 10 patients will be selected on the basis of inclusion and exclusion criteria. Interventional drug will be given to both groups of patient to know the effect of kwatha and churna |