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CTRI Number  CTRI/2024/09/073812 [Registered on: 12/09/2024] Trial Registered Prospectively
Last Modified On: 11/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Virechana followed by shaman dravya,modern drug Omeprazole and lifestyle manangement in Amlapitta 
Scientific Title of Study   Standard controlled clinico-comparative study of Virechana followed by Shamana with lifestyle management in Amlapitta(GERD)  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Astha Shukla 
Designation  PG scholar 
Affiliation  Uttarakhand Ayurveda university,Gurukul campus,Haridwar 
Address  OPD NO. 24,Department of Panchakarma,Uttarakhand Ayurveda University,Gurukul Campus,Haridwar,Uttaranchal 249404

Hardwar
UTTARANCHAL
249404
India 
Phone  7088358858  
Fax    
Email  asthashukla065@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Gyanendra Dutta Shukla 
Designation  Associate Professor 
Affiliation  Uttarakhand Ayurveda university,Gurukul campus,Haridwar 
Address  OPD NO. 24,Department of Panchakarma,Uttarakhand Ayurveda University,Gurukul Campus,Haridwar,Uttaranchal 249404

Hardwar
UTTARANCHAL
249404
India 
Phone  8791265576  
Fax    
Email  dr.gdshukla@gmail.com  
 
Details of Contact Person
Public Query  
Name  Astha Shukla 
Designation  PG scholar 
Affiliation  Uttarakhand Ayurveda university,Gurukul campus,Haridwar 
Address  OPD NO. 24,Department of Panchakarma,Uttarakhand Ayurveda University,Gurukul Campus,Haridwar,Uttaranchal 249404

Hardwar
UTTARANCHAL
249404
India 
Phone  7088358858  
Fax    
Email  asthashukla065@gmail.com  
 
Source of Monetary or Material Support  
Dr.Astha Shukla.Uttarakhand ayurveda university,Gurukul Campus,Haridwar,uttarakhand, India 249404 
 
Primary Sponsor  
Name  Astha Shukla 
Address  Panchakarma PG department ,Uttarakhand ayurveda university,Gurukul Campus,Haridwar,uttarakhand, India 249404 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Astha Shukla  Uttarakhand Ayurveda University,Gurukul campus,Haridwar  OPD NO. 24,Department of Panchakarma,Uttarakhand Ayurveda University,Gurukul Campus,Haridwar,Uttaranchal 249404
Hardwar
UTTARANCHAL 		 7088358858

asthashukla065@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC,UAU,Gurukul campus  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K219||Gastro-esophageal reflux disease without esophagitis. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म Pradhan Karma(Procedure Reference: chakradutta amlpitta chikitsa, Procedure details: virechana drug will be given to patient after purvakarma )
(1) Medicine Name: trivrita avleha, Reference: ch kalpa 7, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(g), Frequency: od, Duration: 1 Days
(2) Medicine Name: aragwadha phalmajjaand trivrita decoction, Reference: ch. kalpa 8, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: od, Duration: 1 Days
(3) Medicine Name: icchabhedi rasa, Reference: rasa yoasagar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: od, Duration: 1 Days
2Comparator Arm (Non Ayurveda)-omeprazoleomeprazole capsule 20mg will be given once before breakfast
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Classical symptoms of Amlapitta as described in Ayurvedic texts viz. Hridkantha Daah (burning
sensation in epigastric region), Aruchi (loss of appetite). Utklesha (Nausea), Tiktaamla Udgaar
(Acid regurgitation), Udar Adhmana (Flatulence), Avipaaka (Indigestion).
2. GERD (Hyperacidity) without any complications.
3. Patients between age group 16-60 years will be selected for the study.
4. Patients who are fit for Virechana Karma.
5. Patients who are willing to give written consent. 
 
ExclusionCriteria 
Details  1.Patients suffering from severe diseases like uncontrolled diabetes, renal disease, liver disease and cardiovascular disease (uncontrolled HTN).
2. Patients who are unfit for Virechana Karma.
3. Lactating and pregnant women. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relief in the symptoms of Amlapitta described below-
Daha,Amlodgara,Shula,Chardi,Avipaka,Aruchi 		 48 days 
 
Secondary Outcome  
Outcome  TimePoints 
Relief in the symptoms of Amlapitta described below-
Daha,Amlodgara,Shula,Chardi,
Avipaka,Aruchi 		 48 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   23/09/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The study is a open,randomised clinical trial to evaluate and compare the efficacy of virechana followed by shaman,modern drug and lifestyle management in Amlapitta(GERD) for the age group 16-60 years for 48 days.This study will be conducted at UAU,Gurukul Campus,Haridwar including 90 patients.Assessment will be done on the basis of subjective criteria.Study will be done on OPD/IPD level of Panchakarma department.One group will be given virechana followed by shaman dravya for 24 days.second group will be given omeprazole capsules for 48 days and third group will be given placebo treatment along with lifestyle management for 48 days.Followup will be done after 1 month .results will be analysed using appropriate tests. 
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