| CTRI Number |
CTRI/2023/10/058695 [Registered on: 16/10/2023] Trial Registered Prospectively |
| Last Modified On: |
23/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of shunti churna in digestive power in Rheumatoid Arthritis |
|
Scientific Title of Study
|
Physiological study of Agni & effect of Shunti churna on Agnibala with special reference to Amavata |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sajeesh U S |
| Designation |
MD Scholar |
| Affiliation |
NATIONAL INSTITUTE OF AYURVEDA, JAIPUR |
| Address |
National institute of Ayurveda(Deemed to be University)
Jaipur, Rajasthan.
SLR - 304 PG Agnivesh boys hostel, Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
8637498447 |
| Fax |
|
| Email |
sajeeshbams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendra prasad |
| Designation |
Associate professor |
| Affiliation |
National institute of ayurveda, Jaipur |
| Address |
National institute of ayurveda
jaipur, Rajasthan.
Room no : 223 Kriya sharir department , National Institute of Ayurveda (Deemed to be University) , Jaipur.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887315717 |
| Fax |
|
| Email |
mprasadmahendra5@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahendra prasad |
| Designation |
Associate professor |
| Affiliation |
National institute of ayurveda, Jaipur |
| Address |
National institute of ayurveda
jaipur, Rajasthan.
Room no : 223 , Kriya Sharir Department ,National Institute of Ayurveda
Jaipur, Rajasthan.
Jaipur
RAJASTHAN
302002
India |
| Phone |
9887315717 |
| Fax |
|
| Email |
mprasadmahendra5@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda,Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda, Jaipur |
| Address |
Jaipur, Rajasthan |
| 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 Sajeesh US |
National Institue Of Ayurveda |
Room no 223 kriya sharir department and opd no 3 National institue of ayurveda, jaipur.
Jaipur
RAJASTHAN |
8637498447
sajeeshbams@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute of Ayurveda, Jorawar singh gate, Amer road, Jaipur - 302002 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M058||Other rheumatoid arthritis with rheumatoid factor. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shunthi, Reference: Bhavprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: -churna is giving in capsule form. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals of either sex between age groups of 18 - 60
2. Individuals suffering from amavata with classical signs and symptoms.
3. Individuals who are having positive blood report of RA Factor. |
|
| ExclusionCriteria |
| Details |
1.Individuals suffering from any other systemic or mental illness.
2. Individuals taking any medicines. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in the agnibala in Amavata |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. changes in the classical signs & symptoms of Rheumatoid arthritis.
2. changes in the value of RA Factor. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/10/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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)
|
Introduction: Agni plays an important role in cause for all the diseases,.In present era the persons lifestyle becomes hectic, lack of exercise, faulty dietary habits like intake of unwholesome food, fast food, beverages, sedentary life styles ,usage of air conditioners, reusage of food items from refregirator have led to many digestive problems ultimately which affects the digestive power ,The main aim of the study is to rectify the agni in patients of Amavata. Aim: To assess the effect of shunthi churna on agnibala in amavata. Objectives: 1.To explore the physiological aspect of Agni 2. To assess the agnibala in amavata 3. To assess the effect of shunthi churna in amavata Primary outcome : 1.Changes in the agnibala in Amavata Secondary outcome: 1. Changes in the signs and symptoms of amavata 2. Changes in the value of RA Factor 3.Changes in the value of serum amylase Inclusion criteria: 1. Individuals of either sex, between age groups of 18 - 60 years 2. Individuals suffering from amavata with classical signs and symptoms 3. Individuals who are having positive blood report of RA Factor Exclusion Criteria: 1. Individuals suffering from any other systemic illness or any such serious adverse effects occur which require emergency management. 2. Individuals taking any other medications. Sample size : 40 Follow up : after every 7 days Duration of the study : 14 days Investigation: RA factor and serum amylase period of study : 18 months
|