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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K296||Other gastritis. Ayurveda Condition: AMLAPITTAM, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [maniziiakayina56@gmail.com].
- 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.
- 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. |