| CTRI Number |
CTRI/2024/11/077266 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
29/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Acute gastritis is a sudden inflammation of the stomach lining, often caused by lifestyle factors and dietary choices and modern medication use. This study aims to evaluate the effectiveness of Gratiola officinalis in treating acute gastritis in women. |
|
Scientific Title of Study
|
To evaluate efficacy of gratiola officinalis homoeopathic medicine in cases of acute gastritis in female. |
| 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.Pritiben Dinubhai Rathwa |
| Designation |
BHMS PG SCHOLER |
| Affiliation |
Parul institute of homoeopathy and research |
| Address |
101(C) Medicine OPD,Parul institute of homoeopathy and research.Ishwarpura, P.o Limda Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8469547034 |
| Fax |
|
| Email |
pritirathwa262@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Pritiben Dinubhai Rathwa |
| Designation |
BHMS PG SCHOLER |
| Affiliation |
Parul institute of homoeopathy and research |
| Address |
Parul institute of homoeopathy and research.Ishwarpura, P.o Limda Vadodara Gujarat India 391760
Vadodara
GUJARAT
391760
India |
| Phone |
8469547034 |
| Fax |
|
| Email |
pritirathwa262@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Pritiben Dinubhai Rathwa |
| Designation |
BHMS PG SCHOLER |
| Affiliation |
Parul institute of homoeopathy and research |
| Address |
101(C) Medicine OPD,Parul institute of homoeopathy and research.Ishwarpura, P.o Limda Vadodara Gujarat,India
Vadodara
GUJARAT
391760
India |
| Phone |
8469547034 |
| Fax |
|
| Email |
pritirathwa262@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul institute of homoeopathy and research.Ishwarpura p.o Limda, vadodara, gujarat,India.391760 |
|
|
Primary Sponsor
|
| Name |
Dr Pritiben Dinubhai Rathwa |
| Address |
Parul institute of homoeopathy and research.Ishwarpura p.o Limda, vadodara, gujarat,India.391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 PRITIBEN DINUBHAI RATHWA |
Parul institute of homoeopathy |
101(c), medicine OPD,Parul institute of homoeopathy and research.Ishwarpura p.o Limda, vadodara, gujarat,India
Vadodara
GUJARAT |
8469547034
pritirathwa262@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PIHR IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K290||Acute gastritis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gratiola Officinalis |
According to susceptibility of the patient I will select the potency,30,200
potency BD, TDS 3-4 days for 3 Month |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Cases will be selected of 18 to 65 age group and only female cases.
Cases will be selected which have detailed history and physical symptoms.
Cases will be selected only acute gastritis.
Willing to adhere to the study protocol and attend follow-up visits.
Select only those cases which totality match with Gratiola officinalis.
|
|
| ExclusionCriteria |
| Details |
Critically Ill patient required hospitalization.
Accidental cases
Patient requiring use of any unacceptable concomitant medication.
Totality not matched with Gratiola officinalis
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the effectiveness of Gratiola officinalis in female
|
12 months for each patient 3-month observation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity & outcome of patient before and after treatment in cases. |
12 months for each patient 3-month observation
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Acute gastritis is a prevalent gastrointestinal disorder influenced by various physiological and lifestyle factors. Traditional treatments often carry significant side effects, highlighting the need for safer alternatives. This clinical study aims to evaluate the efficacy of Gratiola officinalis, a homeopathic remedy, specifically in women. Conducted over 12 months with 30 participants, this prospective, single-arm study will follow Hahnemannian guidelines for treatment and follow-up |