| CTRI Number |
CTRI/2025/06/089312 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
20/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Acidogrit in the Management of Functional Dyspepsia |
|
Scientific Title of Study
|
Evaluate the Clinical Effectiveness of the Ayurvedic Formulation Acidogrit in the Management of Functional Dyspepsia:Prospective,Open Label,Single Arm, Observational Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Preeti Rajpoot |
| Designation |
Physician Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 36
Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8476088686 |
| Fax |
|
| Email |
dr.preeti.rajput18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preeti Rajpoot |
| Designation |
Physician Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 36
Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8476088686 |
| Fax |
|
| Email |
dr.preeti.rajput18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preeti Rajpoot |
| Designation |
Physician Resident Medical Officer |
| Affiliation |
Patanjali Wellness |
| Address |
OPD No 36
Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8476088686 |
| Fax |
|
| Email |
dr.preeti.rajput18@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Research Foundation Governed by Patanjali Research Foundation Trust NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand India |
|
|
Primary Sponsor
|
| Name |
Patanjali Research Foundation |
| Address |
NH 58 Near Bahadrabad Haridwar 249405 Uttarakhand India |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Preeti Rajpoot |
Patanjali Ayurveda Hospital |
OPD No 31
Department of Panchkarma Patanjali Yogpeeth Maharshi Dayanand Gram Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar
UTTARANCHAL |
8476088686
dr.preeti.rajput18@gmail.com |
| Dr Preeti Rajpoot |
Patanjali Wellness |
OPD No 36
Department of Panchkarma Patanjali Wellness Delhi Haridwar National Highway Near Bahadrabad Haridwar 249405 Uttarakhand India
Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL |
8476088686
dr.preeti.rajput18@gmail.com |
| Dr Preeti Rajpoot |
Patanjali Yoggram |
OPD No 16
Department of Panchkarma Patanjali Yoggram Yog Naturopathy Panchkarma Treatment and Research Centre Yoggram Village Aurangabad Near SIDCUL Roshnabad Haridwar 249402 Uttarakhand India
Hardwar
UTTARANCHAL |
8476088686
dr.preeti.rajput18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PATANJALI AYURVED COLLEGE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K30||Functional dyspepsia. Ayurveda Condition: AMLAPITTAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosis of functional dyspepsia/ Postprandial Distress Syndrome (PDS) and Epigastric Pain Syndrome by fulfilling Rome IV criteria
Written informed consent signed by patient and willing to comply with the study procedure.
|
|
| ExclusionCriteria |
| Details |
Subjects having a history of structural disease of Oesophagus Stomach and duodenum.
Subjects having a history of previous abdominal surgery.
Subjects with any active GI Bleeding epigastric mass and peptic ulcer.
Chronic alcoholics and habitual tobacco chewers or any substance abuse.
Pregnant and lactating women.
Any condition the investigator identifies that can confound the participants ability to participate in the study properly.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Global Overall Symptom Scale |
Baseline to Day 30. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Short Form-Nepean Dyspepsia Index |
Baseline to Day 30. |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This
open label, single arm, prospective observational study will assess the
effectiveness of Acidogrit in Functional Dyspepsia patients. Patients will
be screened on the basis of Inclusion/Exclusion criteria and enrolled after
obtaining written Informed consent. The Patients will be followed-up for the
next 30 days from the day of enrolment. Primary and secondary outcome will be
evaluated by assessing Global Overall Symptom Scale and Short
Form-Nepean Dyspepsia Index |