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CTRI Number  CTRI/2023/05/053006 [Registered on: 22/05/2023] Trial Registered Prospectively
Last Modified On: 19/05/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate the effectiveness of vidanga(Embelia ribes) powder in the management of Gastritis caused by infection (Helicobacter pylori) 
Scientific Title of Study   Clinical study to evaluate the efficacy of vidanga churna in the management of Urdhwaga Amlapitta due to Helicobacter pylori. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr S Maniziia 
Designation  PG scholar 
Affiliation  Government Ayurvedic college and Hospital GHY 14  
Address  Government Ayurvedic college and Hospital Guwahati 14 Department of Kayachikitsa Jalukbari

Kamrup
ASSAM
781014
India 
Phone  7085712596  
Fax    
Email  maniziiakayina56@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Maniziia 
Designation  PG scholar 
Affiliation  Government Ayurvedic college and Hospital GHY 14  
Address  Government Ayurvedic college and Hospital Guwahati 14 Department of Kayachikitsa Jalukbari


ASSAM
781014
India 
Phone  7085712596  
Fax    
Email  maniziiakayina56@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ranjan kalita  
Designation  Lecturer 
Affiliation  Government Ayurvedic college and Hospital GHY 14  
Address  Government Ayurvedic college and Hospital Guwahati 14 Department of Kayachikitsa Jalukbari

Kamrup
ASSAM
781014
India 
Phone  86382113399  
Fax    
Email  ranjankalita1972@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurvedic College and Hospital Jalukbari GHY 14 
 
Primary Sponsor  
Name  Dr S Maniziia 
Address  Government Ayurvedic College and Hospital Jalukbari Guwahati Assam 781014 
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 S Maniziia   Government Ayurvedic College and Hospital  Department of kayachikitsa Govt Ayurvedic College and work Jalukbari
Kamrup
ASSAM 
7085712596

maniziiakayina56@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE GOVERNMENT AYURVEDIC COLLEGE AND HOSPITAL JALUKBARI GUWAHATI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K296||Other gastritis. Ayurveda Condition: AMLAPITTAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Vidanga churna , Reference: Indradev Tripathi Chakra datta krimi chikitsa 7, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -shunthi yasthimadhu kwath), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Symptoms-
1.Sour or bitter eructation/belching
2.nausea, pyrosis, water brash,
3.Indigestion,Loss of appetite
4.Gaseous distension, heaviness of body
5.Positive Helicobacter pylori in upper GI endoscopy yr 
 
ExclusionCriteria 
Details  1.Any Cancer of Gastrointestinal tract
2.Past history of Abdominal surgery
3.Pregnant and lactating mother
4.Patients of major systemic illness including Cardiac, hepatobiliary, kidney and IBS
5.Hiatus hernia
6.Major Oral pharyngeal and laryngeal infections 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.To Decrease the symptoms of pyrosis,nausea,sour eructation, bloating, abdominal pain
2.To improve digestion and appetite 
60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Upper Gastrointestinal Endoscopy with negative H.pylori(RUT)  60 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/06/2023 
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="0"
Months="9"
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)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [maniziiakayina56@gmail.com].

  6. For how long will this data be available start date provided 18-09-2021 and end date provided 15-02-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This is a clinical study to evaluate the efficacy of Vidanga churna in the management of Urdhwaga amlapitta due to helicobacter pylori. This is done as a mandatory part of Post Graduation. Total number of 60 patients will be studied in 60 days each. 
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