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CTRI Number  CTRI/2023/12/060858 [Registered on: 27/12/2023] Trial Registered Prospectively
Last Modified On: 18/12/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Other 
Public Title of Study   Homoeopathy in the management of irritable bowel syndrome. 
Scientific Title of Study   Efficacy of Individualized Homoeopathic medicines or Bowel nosodes compared to placebo in irritable bowel syndrome: A three-armed, randomized, parallel group, placebo-controlled, double-blind, interventional 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 Shweta Gautam 
Designation  Research Officer (Homoeopathy), Scientist-1 
Affiliation  Dr D P Rastogi Central Research Institute for Homoeopathy 
Address  Room No. 226, Dr D P Rastogi Central Research Institute for Homoeopathy. A-1/1, Sector 24, Noida.

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9999566890  
Fax    
Email  dr.shwetagtm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shweta Gautam 
Designation  Research Officer (Homoeopathy), Scientist-1 
Affiliation  Dr D P Rastogi Central Research Institute for Homoeopathy 
Address  Room No. 226, Dr D P Rastogi Central Research Institute for Homoeopathy. A-1/1, Sector 24, Noida.

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  9999566890  
Fax    
Email  dr.shwetagtm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shweta Gautam 
Designation  Research Officer (Homoeopathy), Scientist-1 
Affiliation  Dr D P Rastogi Central Research Institute for Homoeopathy 
Address  Room No. 226, Dr D P Rastogi Central Research Institute for Homoeopathy. A-1/1, Sector 24, Noida.

Purnia
UTTAR PRADESH
201301
India 
Phone  9999566890  
Fax    
Email  dr.shwetagtm@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Homoeopathy, 61-65, Institutional area, Opp. D Block, Janakpuri, New Delhi,110058. 
 
Primary Sponsor  
Name  Central Council for Research in Homoeopathy 
Address  Central Council for Research in Homoeopathy, 61-65, Institutional area, Opp. D Block, Janakpuri, New Delhi,110058. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr K K Avinash  Clinical Verification Unit for Homoeopathy  Room No.210,Clinical Verification Unit for Homoeopathy, 2nd floor, Shree Guru Govind Singh Sadar Hospital, Patna City-800008, Bihar
Patna
BIHAR 
8638256346

krkeshav82@gmail.com 
Dr Shweta Gautam  Dr. D P Rastogi Central Research Institute for Homoeopathy  Room No. 226, A-1/1, Sector-24, Noida. Uttar Pradesh-201301.
Gautam Buddha Nagar
UTTAR PRADESH 
9999566890

dr.shwetagtm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Central Ethics Committee, Central Council for Research in Homoeopathy   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K58||Irritable bowel syndrome,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bowel Nosodes + dietary modifications  Known homoeopathic preparations in different potencies along with dietary modifications for 6 months 
Comparator Agent  Identical placebo + dietary modifications  unmedicated sugar pills along with dietary modifications for 6 months. 
Intervention  Individualized homoeopathic medicines + dietary modifications  Known homoeopathic pharmacopoeial preparations in different potencies along with dietary modifications for 6 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  i)Patients fulfilling the Rome IV criteria.
ii)Adults both male and female aged 18 to 60 years.
iii)The willingness to document bowel symptoms and medication use regularly and to complete the assessments.
 
 
ExclusionCriteria 
Details  i)Pregnant or breast feeding female.
ii)Patient who had prior abdominal surgery which may cause bowel symptoms similar to IBS.
iii)Those who had other gastro-intestinal diseases including Colitis, Crohn’s disease, Coeliac disease and Chronic pancreatitis.
iv)Those who were currently participating in another trial or had been in a trial within the previous three months.
v)Patient with any uncontrolled co-morbidities (Hypertension, Diabetes Mellitus, Liver disease, kidney disease, heart disease, hypo or hyperthyroidism etc.)
vi)Patients who are alcoholics.
vii)Patient taken antispasmodics, opiates/anti-diarrhoeal drugs, NSAIDs, long-term antibiotics, other anti- inflammatory drugs in the last 15 days.
viii)Poor treatment compliance (e.g. unstable working and living situation, difficult follow-up).
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the changes in quality of life using IBS-QoL over 6 months.  At baseline and then every month over 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the changes in the IBS-SSS scores from baseline over 6 months.  Fortnightly for 6 months 
To evaluate the mean stool consistency using Bristol Stool Form Score over 6 months.  Fortnightly for 6 months 
To compare the changes in stool culture before and after homoeopathic treatment.  At baseline and at end of 6 months 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 
Date of First Enrollment (India)   01/01/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   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  

Irritable bowel syndrome (IBS) is a functional gastrointestinal disorder which is characterized by abdominal pain and abnormal defecation patterns. The global prevalence is estimated between 10% and 20%. IBS is classified into four subtypes: IBS with predominant constipation (IBS-C), IBS with predominant diarrhea (IBS-D), with mixed bowel habits (IBS-M) or IBS, unsubtyped. IBS manifests as a collection of gastrointestinal symptoms that change significantly from patient to patient and return on an episodic basis. Abdominal pain or abdominal discomfort with altered bowel habit is the predominant feature of IBS. There may be alternating diarrhea and constipation, and other associated symptoms include mainly gas bloating, which is temporarily relieved by defecation, upper gastrointestinal symptoms like dyspepsia, heartburn etc. Many patients with IBS suffer from visceral hypersensitivity i.e. ‘feel their gut too much’, from anxiety, depressed mood and various symptoms from many other regions of the body (a phenomenon called somatization). This condition is associated with impaired quality of life and limitations in daily activities, without affecting overall survival. The economic burden of the disease is substantial at the individual, healthcare system and societal levels. Severe IBS can significantly alter quality of life,      disrupt daily activities, and result in inflated healthcare costs. As IBS is merely a symptom-based condition so it can be better managed or treated by homoeopathy which is also based upon the principle of symptom similarities. Individualization is the process of arriving at the image of the patient for the selection of remedy. The customary way of individualization of the patient is through the construction of totality of symptoms according to which Similimum is prescribed. Along with constitutional medicines based on individualization there is another group of medicines that have been prepared and proven from the human gut flora named Bowel Nosodes. Since homeopathy’s effectiveness for irritable bowel syndrome has not yet been exhaustively investigated, more studies that adhere to the highest methodological standards are required. In this study we aim to assess the efficacy of individualized homoeopathic medicines or bowel nosodes compared to placebo with regard to disease-specific quality of life in patients with IBS. Along with it symptom severity of IBS, stool consistency and stool culture of patients will be assessed. Dietary modifications will be given in all the three groups.


 
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