| 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
|
|
|
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
|
|
|
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. |