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CTRI Number  CTRI/2026/02/102819 [Registered on: 02/02/2026] Trial Registered Prospectively
Last Modified On: 31/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Role of Homoeopathic medicines Croton tiglium and Lycopodium clavatum in the treatment of Irritable Bowel Syndrome  
Scientific Title of Study   Assessing the effectiveness of Homoeopathic Medicines Croton tiglium and Lycopodium clavatum in the treatment of Irritable Bowel Syndrome- An Open Label Randomized Controlled Trial 
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 Pralhad  
Designation  PG student 
Affiliation  Government Homoeopathic Medical College and Hospital  
Address  Government Homoeopathic Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwara Nagar Bangalore Ground floor Room Number 22 OPD

Bangalore
KARNATAKA
560079
India 
Phone  8660876537  
Fax    
Email  pralhadshedole866@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Pralhad  
Designation  PG student 
Affiliation  Government Homoeopathic Medical College and Hospital  
Address  Government Homoeopathic Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwara Nagar Bangalore Ground floor Room Number 22 OPD

Bangalore
KARNATAKA
560079
India 
Phone  8660876537  
Fax    
Email  pralhadshedole866@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pralhad  
Designation  PG student 
Affiliation  Government Homoeopathic Medical College and Hospital  
Address  Government Homoeopathic Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwara Nagar Bangalore Ground floor Room Number 22

Bangalore
KARNATAKA
560079
India 
Phone  8660876537  
Fax    
Email  pralhadshedole866@gmail.com  
 
Source of Monetary or Material Support  
Dr Pralhad Government Homoeopathic Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwara Nagar Bangalore Ground floor Room No 22 
 
Primary Sponsor  
Name  Dr Pralhad  
Address  Government Homoeopathic Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwara Nagar Bangalore Ground floor Room No 22 
Type of Sponsor  Other [Principal Investigator] 
 
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 Pralhad  Government Homoeopathic Medical College and Hospital Bangalore   Government Homoeopathic Medical College and Hospital Dr Siddaiah Puranik Road Basaveshwara Nagar Bangalore 560079 Ground floor Room Number 22
Bangalore
KARNATAKA 
8660876537

pralhadshedole866@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Homoeopathic Medical College and Hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K582||Mixed irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Croton tiglium   To assess the effectiveness of Croton tiglium in the treatment of Irritable Bowel Syndrome  
Comparator Agent  Lycopodium clavatum   To assess the effectiveness of Lycopodium clavatum in the treatment of Irritable Bowel Syndrome  
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Subjects who are voluntarily willing to take part in this study and sign the written informed consent
Subjects between age group of 21 to 45 years
Diagnosed new cases of Irritable Bowel Syndrome using the Rome IV criteria  
 
ExclusionCriteria 
Details  Subjects having alarming features like anemia, unintended weight loss, nocturnal diarrhea, blood in stool, persistent diarrhea
Subjects with systemic illness
Subjects with severity scoring system greater than or equal to 300
Pregnant and Lactating women  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Recovered-Subjects with complete relief in the clinical symptoms with IBS severity score will be zero  The severity and intensity of the subjects will be assessed using IBS Severity Scoring System on the first visit to determine the baseline score The follow up of the case will be assessed by IBS Severity Scoring System which
will be assessed once in 10 days for first 3 months and once in a month for next 3
months 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life
 
By the end of 6 months 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   13/02/2026 
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 Applicable 
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   Irritable Bowel Syndrome(IBS) is a functional bowel disorder in the absence of detectable structural abnormalities. There is no clear diagnostic markers for IBS.  Thus, the diagnosis is based on history and clinical presentation.
Symptoms of the condition include abdominal pain,  diarrhea,  constipation,  mucus discharge per rectum and altered stool appearance.  The genesis of disease is complex with multiple factors contributing to its occurrence.  Cause of IBS is not fully known,  but biopsychosocial variables are likely to play an essential role,  along with luminal factors such as diet and the gut flora.
A complex combination of components,  including psychological stress,  hormones,  the immune system and neurotransmitters appear to disrupt communication between the brain and the gut. The prevalence of Irritable Bowel Syndrome in Western countries ranges from 4-5%., in Asian countries 1-10% and in India prevalence is estimated at 4-7.9%. The prevalence in North India is 4%.
Irritable Bowel Syndrome is a multifactorial disorder and it should be treated by considering various factors including mental status of the patient. Homoeopathy is a viable therapeutic option,  since it takes into account diseased individual rather than disease- a holistic approach which includes various factors like mode of living,  habits,  occupation,  mind and disposition along with the physical symptoms.
Homoeopathic medicines like Croton tiglium and Lycopodium clavatum, which were well proved and documented in source books. There are different literature shows that Lycopodium clavatum is well indicated for Irritable Bowel Syndrome. The action of Croton tiglium on gastrointestinal system is,  it alters the bowel habits by affecting contractile frequency and amplitude of intestinal smooth muscles. Hence, this study is intended to assess and compare the effectiveness of these two medicines in the treatment of Irritable Bowel Syndrome.
 
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