| CTRI Number |
CTRI/2018/03/012546 [Registered on: 13/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
25/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Virechana karma
(Purgation therapy )and Khanda Pippaliavaleha
(Ayurvedic formulation ) in the treatment of acidity |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Virechana karma and Khanda Pippaliavaleha in the management of Amlapitta |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Alok Kumar Srivastava |
| Designation |
Professor |
| Affiliation |
Rishikul Campus, Haridwar, Uttarakhand Ayurved University , Dehradun |
| Address |
Department of Panchkarma,Rishikul Campus , Haridwar,UAU,Dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9045087121 |
| Fax |
01334-220236 |
| Email |
virgo.alok@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anshul |
| Designation |
PG scholar |
| Affiliation |
Rishikul campus ,Uttarakhand Ayurved University |
| Address |
Department of Panchkarma, Rishikul Campus ,Haridwar, UAU,Dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9416470813 |
| Fax |
|
| Email |
dr.anshul17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anshul |
| Designation |
PG scholar |
| Affiliation |
Rishikul campus ,Uttarakhand Ayurved University |
| Address |
Department of Panchkarma, Rishikul Campus ,Haridwar, UAU,Dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9416470813 |
| Fax |
|
| Email |
dr.anshul17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rishikul campus,Haridwar,249401
Uttarakhand Ayurved University,Harrawala, Dehradun, 248001 |
|
|
Primary Sponsor
|
| Name |
Rishikul campus Haridwar |
| Address |
Uttarakhand Ayurved University Harrawala
248001 |
| Type of Sponsor |
Other [Government University] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sanjay Tripathi |
Department of Kaya Chikitsa, Rishikul Campus, Uttarakhand Ayurved University , Dehradun |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Alok Kumar Srivastava |
Rishikul Campus |
Department of Panchkarma
Room no 20
Hardwar
UTTARANCHAL |
9045087121
virgo.alok@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K290||Acute gastritis, Amlapitta( hyperacidity), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Khand pippali Awaleha |
Khand Pippali avaleha 5 g BD for 2 months
and follow up after 30 days |
| Intervention |
Virechana karma |
1 Sitting of virechana karma followed by placebo for 45 days with water |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Amlapitta defined as those patients with burning sensation in epigastric region(hritkanthadaha),loss of appetite(aruchi),nausea(utklesh ),acid reflux( tiktamlodgar) , flatulence( adhman),constipation ( vibandha),bhrama (reeling oh head),fatigue(klama),indigestion (avipaka),vomiting (chardi) |
|
| ExclusionCriteria |
| Details |
age below 20 yr and more than 60 yr,
known case of Gastric and Duodenal ulcer ,
known case of gastritic carcinoma
Chronic gastritis( more than 1 yr)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wilcoxon signed rank test
Independent sample t test
Man-Whitney test |
Outcome will be asssesed after 60 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not yet completed |
Not yet completed |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
09/01/2017 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/02/2018 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
In Proccess of publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Purpose : Evaluation of treatment modalities of Amalpitta in Ayurveda having no side effect and permanent relief. Background : Contents of Khand pippali awaleha are cost effective and their properties ( sheet veerya, madhur vipaka) seems to be very effective in controlling disease. Virechana is easy carry out ,less stressful and after this their is no reoccurrence of disease .
Findibgs : Trial yet to be completed . |