| CTRI Number |
CTRI/2024/05/068163 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
Homeopathy in functional gastric diseases |
|
Scientific Title of Study
|
A Prospective Experimental Study To Ascertain The Effectiveness Of Homeopathic Medicines In Functional Gastrointestinal Disorders Using Mymop Scale |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka A Nasit |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homeopathic Medical College |
| Address |
Department of homeopathic materia Medica, rajkot Homeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, rajkot, gujarat
Rajkot
GUJARAT
360001
India |
| Phone |
6353058761 |
| Fax |
|
| Email |
priyankanasit04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sanja |
| Designation |
MD HOM HOD and professor Homeopathic Materia Medica |
| Affiliation |
Rajkot Homeopathic Medical College |
| Address |
Department of homeopathic materia Medica, rajkot Homeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9825885350 |
| Fax |
|
| Email |
drrajeshsanja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka A Nasit |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homeopathic Medical College |
| Address |
Department of homeopathic materia Medica, Rajkot Homeopathic Medical College, behind jainath complex, makkam chowk, Gondal road, rajkot, gujarat
Rajkot
GUJARAT
360002
India |
| Phone |
6353058761 |
| Fax |
|
| Email |
priyankanasit04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homeopathic Medical College Behind Jainath complex Gondal road 360002 rajkot gujarat India |
|
|
Primary Sponsor
|
| Name |
Rajkot Homeopathic Medical College |
| Address |
Behind jainath complex, makkam chowk, Gondal road,360002 Rajkot Gujarat India |
| Type of Sponsor |
Private medical college |
|
|
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 Priyanka A Nasit |
Sainath homeopathic hospital |
Department of Homeopathic Materia Medica, Rajkot Homeopathic Medical College, behind jainath complex, Gondal road, rajkot, Gujarat
Rajkot
GUJARAT |
6353058761
priyankanasit04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human research- Rajkot Homeopathic Medical College (RHMC), parul University Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised homeopathic medicine |
Individualised homeopathic medicine selected according to totality. Selection of potency, doses and repetition will be done according to the susceptibility of patient and principles of organon of medicine. Dose will be given according to the case 30,200,1M, on the basis of susceptibility of patient, mode of administration will be oral. Frequency of repitition every week and modified as per requirement of patient and followed up for duration of 9 months. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from functional gastrointestinal disorders
Age group between 20-60 years
Both genders will be included |
|
| ExclusionCriteria |
| Details |
Patients suffering from gross pathological changes, bed ridden patients, mentally retarded patients, who need hospitalization and under treatment of other systems of medicine.
Patients of age group less than 20 and more than 60
Pregnant females and lactating mothers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effectiveness of Individualised Homeopathic Medicines in cases of functional gastrointestinal diseases with the help of mymop scale |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the effectiveness of Individualised homeopathic medicines
in cases of functional gastrointestinal disorders diagnosed with the help of ROME IV criteria
To know the impact on quality of life of patients |
20 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/06/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Functional gastrointestinal disorders is also called hut brain interaction. Although these disorders are not life threatening, but lingering cases, it has. A significant impact on quality of life. Functional disorders of the digestive tract cause sign and symptoms without any evidence of organic disease. They include primary dyspepsia, irritable bowel syndrome. Gastrointestinal symptoms are widespread and carry heavy economical and social consequences. In India the prevalence of functional gastrointestinal disorders is 18 percent. According to master Hahnemann, it is the morbidly affecting vital force that produces disease Homeopathy belives in individuality. So we treat the patient as a whole. |