| 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
|
|
|
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
|
|
|
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. |