| CTRI Number |
CTRI/2021/11/038320 [Registered on: 29/11/2021] Trial Registered Prospectively |
| Last Modified On: |
26/11/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
study of Amavata and to asses the therapeutic efficacy of shunthi churna on Rheumatoid arthritis. |
|
Scientific Title of Study
|
An Aetiopathological Study of Amavata With Special Reference to Rasavaha Srotodisthi and Upashayatmaka trial with Shunthi Churna |
| Trial Acronym |
SARS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod Singh |
| Designation |
MD (Ay) scholar |
| Affiliation |
Goverment Ayurvedic college patna |
| Address |
Department of Rognidan, Goverment Ayurvedic college Patna
Patna
BIHAR
800003
India |
| Phone |
7579453202 |
| Fax |
|
| Email |
vinodtitiyal2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amrendara Kumar Singh |
| Designation |
Associate professor |
| Affiliation |
Goverment Ayurvedic college patna |
| Address |
Department of Rognidan, Goverment Ayurvedic college Patna
Patna
BIHAR
800003
India |
| Phone |
7013506981 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrendara Kumar Singh |
| Designation |
Associate professor |
| Affiliation |
Goverment Ayurvedic college patna |
| Address |
Department of Rognidan, Goverment Ayurvedic college Patna
Patna
BIHAR
800003
India |
| Phone |
7013506981 |
| Fax |
|
| Email |
singh.amrendra70@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Goverment Ayurvedic college patna |
|
|
Primary Sponsor
|
| Name |
Goverment Ayurvedic college patna |
| Address |
Department of Rognidan Goverment Ayurvedic college patna |
| 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 vinod singh |
Goverment Ayurvedic college Patna |
Department of Rognidan avum Vikriti Vigyan Government Ayurvedic College Patna
Patna
BIHAR |
7579453202
vinodtitiyal2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M00-M99||Diseases of the musculoskeletal system and connective tissue. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthi churna, Reference: Bhasajya Ratnawali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The sign and symptom based on both Ayurvedic as well as modern view.
Classical symptoms of rheumatoid arthritis have diagnose on basis of ACR criteria. |
|
| ExclusionCriteria |
| Details |
Immunocompromised patients.
Severe deformities
Any complication e.g. Diabetes Mellitus, Tuberculosis etc.
Pregnant and lactating women not included in the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| CURE |
cure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cure |
Cure |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
29/11/2021 |
| 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)
|
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
|
The disease Amavata is a one amongst them which have causative factors as described in Ayurvedic text are sedentary habits, incompatible diet and regimen, physical exercise etc, According to the Ayurvedic texts the Amavata is a disease of rasavaha srotas and mandagni is an important contributing factor in its pathogenesis. In modern science the aetiopathology of the disease is not very clear, whereas in Ayurvedic text a set of aetiological factors are mentioned.Chronic condition may cause debility, deformitites of joints and crippling, unfortunately due to unknown aetiology there is no effective treatment is availavable in modern science. Shunthi is a well known drug having vatakaphahara properties and due to katu rasa, ushna veerya it is used in mandagni. |