| CTRI Number |
CTRI/2020/07/026358 [Registered on: 04/07/2020] Trial Registered Prospectively |
| Last Modified On: |
30/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Management of Indigestion by Ayurvedic Method |
|
Scientific Title of Study
|
An Etiopathogical Study of Ajirna (Indigestion) and The Therapeutic Effect (Upshayatmak Parikshana) of Shailparashar Churna (Kalpit Yoga) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
LOVE KUMAR PARASHAR |
| Designation |
MD SCHOLAR |
| Affiliation |
Govt PG Ayurveda College And Hospital Varanasi |
| Address |
Roga Nidan department OPD NO 10 Govt PG Ayurveda College Chaukhaghat Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9571959356 |
| Fax |
|
| Email |
lavparashar110593@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
SHAILENDRA KUMAR SINGH |
| Designation |
Lecturer |
| Affiliation |
Govt PG Ayurveda College And Hospital Varanasi |
| Address |
Dept of Roga Nidan Govt PG Ayurveda College Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453360096 |
| Fax |
|
| Email |
singhshailendra1001@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHAILENDRA KUMAR SINGH |
| Designation |
Lecturer |
| Affiliation |
Govt PG Ayurveda College And Hospital Varanasi |
| Address |
Dept of Roga Nidan Govt PG Ayurveda College Varanasi
Varanasi
UTTAR PRADESH
221002
India |
| Phone |
9453360096 |
| Fax |
|
| Email |
singhshailendra1001@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt PG Ayurveda College And Hospital Sampurnanand Sanskrit University Varanasi |
|
|
Primary Sponsor
|
| Name |
Govt PG Ayurveda College And Hospital Chaukaghat Varanasi |
| Address |
Govt PG Ayurveda College And Hospital Chaukaghat Varanasi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| LOVE KUMAR PARASHAR |
PG Government Ayurved Hospital Varanasi |
Dhupchandi Jaitpura Varanasi Uttar Pradesh 221001
Varanasi
UTTAR PRADESH |
9571959356
lavparashar110593@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: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
SHAILPARASHAR CHURNA |
MINIUM 40 PATIENTS OF AJIRNA WILL BE GIVEN 5GM SHAILPARASHAR CHURNA TWICE A DAY FOR 30 DAYS |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient suffering from Ajirna (Indigestion)
Patient between age group 16 to 70 years of both sex |
|
| ExclusionCriteria |
| Details |
1 Age below 16 and above 70 years patients
2 Suffering from malignancies and Chronic systemic diseases like Uncontrolled Hypertension (180/120 mmHg) Uncontrolled diabetes [above the range of 160-200 mg dl(RBS)] Venereal diseases
3 Ajirna causes due to constant medication
4 Patients having any anatomical deformity in Digestive tract
5 Mental retard person/psychological disable person
6 Congenital deformity including brain & Spinal cord
7 Drug addicted person
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in Sign and Symptoms of Ajirna |
one month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improve Quality of Life of Person |
After 5 weeks from day of Enrollment. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/07/2020 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Under this Clinical Study Minimum 40 Patients of Ajirna will be Treated with Shailparashar Churna.This Medication have Deepan,Pachan,Vatanuloman Properties which act on Agni and Cure Agnimandhya and Other Associated Symptoms. The Period of trial will be one month with seven days follow up. Patient will be Selected from the O.P.D. and I.P.D. and will be Diagnosed on the basis of Sign and Symptoms and Lab Investigations and Radiological Investigations,then Assessment will be done and Conclusion will be Drawn after completion of Study. |