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CTRI Number  CTRI/2025/10/095882 [Registered on: 10/10/2025] Trial Registered Prospectively
Last Modified On: 09/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Study The Utility Of Repertory Of The Homoeopathic Therapeutics Of Diarrhoea By Dr James B Bell In The Management Of Acute Watery Diarrhoea In Adults 
Scientific Title of Study   Study The Utility Of Repertory Of The Homoeopathic Therapeutics Of Diarrhoea By Dr James B Bell In The Management Of Acute Watery Diarrhoea In Adults An Experimental Non-Controlled 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 Arsheen Shaikh 
Designation  PG Student 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute  
Address  Department Of Repertory Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9653304171  
Fax    
Email  arsheensk120517@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shrutika Sawant  
Designation  HOD Professor 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute  
Address  Department of Repertory Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9833674469  
Fax    
Email  shruti_0708@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Chintan V Mehta 
Designation  Associate professor 
Affiliation  Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute  
Address  Department of Homoeopathic Materia Medica Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai 410210

Raigarh
MAHARASHTRA
410210
India 
Phone  9869021226  
Fax    
Email  omcvm@yahoo.co.in  
 
Source of Monetary or Material Support  
Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute  
 
Primary Sponsor  
Name  Dr Arsheen Shaikh 
Address  Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai 410210 
Type of Sponsor  Other [Self Sponser] 
 
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 Arsheen Shaikh  OPD 1 (Medicine)Dr G D Pol Foundation YMT Homoeopathic Medical College   OPD 1 (Medicine) Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute Institutional Area Sector 4 Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA 
9653304171

arsheensk120517@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr G D Pol Foundation YMT Homoeopathic Medical College Hospital And PG Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Management with Individualised homoeopathic medicine with Bells repertory  Single dose of Individualised homoeopathic medicine orally according to Bells repertory and follow up after 7 days or till improvement which is earlier 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients having Acute diarrhoea for less than 14days
Patients of age group 18-40 years
Patients of all genders
Patients with mild dehydration
 
 
ExclusionCriteria 
Details  Suspected immunocompromised patients
Patients taking any medications that have confounding effect
Pregnant and lactating female
Patients with moderate and severe dehydration
Patients presenting with symptoms of any other diseases
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome will be assessed in terms of
Improved
Not improved
Based on Likerts 4 point scale for acute watery diarrhoea follow up will be carried every 7 days or earlier if required till remission. 
Duration of study- 18 month

Duration of each case- 14days or till remission of symptom.

Duration of follow up of each case- Outcome will be assessed clinically every 7 days or earlier if required. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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   N/A 
Date of First Enrollment (India)   30/10/2025 
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="1"
Months="6"
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  

1A40.Z - Acute watery diarrhoea.

Diarrhoea is an alteration in normal bowel movement, characterized by increased frequency, volume, and water content of stools. It is clinically defined as an increase in stool frequency to three or more liquid or semi-formed motions in 24 hours or more. Acute diarrhoea is defined as diarrhoea of 14 days duration or less.

Diarrhoea is loosely defined as passage of abnormally liquid or unformed stools at an increased frequency. Diarrhoea may be further defined as acute if <2 weeks, persistent if 2–4 weeks, and chronic if >4 weeks in duration.

Acute watery diarrhoea is a manifestation under "Gastrointestinal Disorders".

Causes of acute diarrhoea are mostly bacterial, viral, and parasitic infection. The route of transmission of infection is through faeco-oral route, or via eating or drinking contaminated food. Poverty and poor environmental hygiene may also contribute to infection. Acute diarrhoea may last for 7-14 days, if it occurs for more than 14days, it is called persistent diarrhoea. Diarrhoea may lead to dehydration in the body as the body tries to maintain its fluid and electrolyte balance for proper functioning but when the loss is more, the body gets dehydrated.

 

 

 

 

ACUTE WATERY DIARRHOEA.

Diarrhoea is an alteration in normal bowel movement, characterized by increased frequency, volume, and water content of stools. It is clinically defined as an increase in stool frequency to three or more liquid or semi-formed motions in 24 hours or more. Acute diarrhoea is defined as diarrhoea of 14 days duration or less.[2]

Diarrhoea is loosely defined as passage of abnormally liquid or unformed stools at an increased frequency. Diarrhoea may be further defined as acute if <2 weeks, persistent if 2–4 weeks, and chronic if >4 weeks in duration.[3]

OBJECTIVES.

1. To study the utility of repertory of The Homoeopathic Therapeutics of Diarrhoea by James B Bell in the management of Acute watery diarrhoea among adults.

2.  Comparison of pre and post treatment score based on pre-validated 4 point Likert scale for acute Diarrhoea.

3.  To study the rubrics related to diarrhoea from The Homoeopathic Therapeutics of Diarrhoea By James B Bell.

4. To study the etiology and pathophysiology of acute watery diarhhoea.

METHODOLOGY.

I) STUDY DESIGN: An Experimental Non-Controlled Study

2) STUDY SETTING: Cases will be collected from the OPD of the Institute.

3) STUDY POPULATION: Clinically diagnosed cases of Acute watery diarrhoea among adults.

4) DURATION OF STUDY: 18 months.

 

5) METHODS OF SELECTION OF STUDY SUBJECT:

1. Inclusion Criteria:

 Patients having Acute diarrhoea for less than 14days

 Patients of age group 18-40 years

Patients of all genders

Patients with mild dehydration

2. Exclusion Criteria:

 Suspected immunocompromised patients

Patients taking any medications that have confounding effect

 Pregnant and lactating female

 Patients with moderate and severe dehydration

Patients presenting with symptoms of any other diseases

3. Subject withdrawal criteria:

a. Patients who does not wish to continue the treatment.

b. Patients who do not give follow up regularly.

6) METHOD OF SELECTION OF COMPARISON OR CONTROL GROUP AND MATCHING CRITERIA:  Not Applicable

7) OPERATIONAL DEFINITION:

Diarrhoea-  Diarrhoea is an alteration in normal bowel movement, characterized by increased frequency, volume, and water content of stools. It is clinically defined as an increase in stool frequency to three or more liquid or semi-formed motions in 24 hours or more. Acute diarrhoea is defined as diarrhoea of 14 days duration or less

Diarrhea is loosely defined as passage of abnormally liquid or unformed stools at an increased frequency.  Diarrhea may be further defined as acute if <2 weeks, persistent if 2–4 weeks, and chronic if >4 weeks in duration

 

4 Point Likert scales used to assess symptoms of acute diarrhoea.

                                           Symptom score

 

0

1

3

3

General well being

Good

Impaired

Bad

Very bad

Stool frequency

<  2

3-5

6-8

> 9

Stool consistency

Hard or normal

Somewhat loose

Runny

Watery

Blood or mucus in stool

None

Some

Moderate

Many

Flatulence

Absent

Mild

Moderate

Severe

Pain intensity

Absent

Mild

Moderate

Severe

Pain persistency

Absent

Sporadic

Prolonged with relief after defecation

Persistant

Nausea and/or vomiting

Absent

Mild

Moderate

Severe

 

3. Outcome assessment criteria

A. An overall mean total symptom score will be calculated including all subgroups which is as follows:

Unsatisfactory= 1

Satisfactory =2

Good = 3

Very Good= 4

 B. Outcome Pre and Post treatment will be assessed according to  4 Point Likert scale for     acute diarrhoea

Improved

Not improved

These criteria will be assessed as per the clinical symptoms presented by the patient.

SAMPLE SIZE:  30 subjects will be selected.

DATA MANAGEMENT AND ANALYSIS PROCEDURE:

1. Framing of totality of symptoms- Will be done as per the principles of Homoeopathy.

2. Selection of remedy- Individualized Homoeopathic Medicines based on totality of symptoms. 

3. The Posology- Appropriate potency will be selected based on the susceptibility of each case. Potency will be changed when required. 

4. Duration of study – 18 months

5. Duration of each case –   Each case will be observed for 15 days or till improvement appeared as per decided scale.

6. Duration of follow up of each case – Every 7 days and early if required.

 

 

 

 
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