| CTRI Number |
CTRI/2019/12/022275 [Registered on: 06/12/2019] Trial Registered Prospectively |
| Last Modified On: |
06/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Stress As A Reactive Pattern To Irritable Bowel Syndrome |
|
Scientific Title of Study
|
Evaluation Of Homoeopathic Treatment On Stress As A Reactive Pattern To Irritable Bowel Syndrome:An Observational Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhranshu prabha mishra |
| Designation |
PG SCHOLAR |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
POM Department, Basement, Bakson Homoeopathic Medical College & Hospital,Greater Noida,Uttar Pradesh
Greater Noida,Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8763513153 |
| Fax |
|
| Email |
subhranshuprabha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhranshu prabha mishra |
| Designation |
PG SCHOLAR |
| Affiliation |
Bakson Homoeopathic Medical College And Hospital |
| Address |
POM Department, Basement, Bakson Homoeopathic Medical College & Hospital,Greater Noida,Uttar Pradesh
Greater Noida,Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India
UTTAR PRADESH
201306
India |
| Phone |
8763513153 |
| Fax |
|
| Email |
subhranshuprabha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rashmi Chowdhury |
| Designation |
Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
POM Department, Basement, Bakson Homoeopathic Medical College & Hospital,Greater Noida,Uttar Pradesh
Greater Noida,Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201306
India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8826797839 |
| Fax |
|
| Email |
dr.rashmichowdhury@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson homoeopathic medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Bakson Homoeopathic Medical College & Hospital,Greater Noida,Uttar Pradesh Greater Noida,Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 201306 India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Subhranshu prabha mishra |
1. Bakson Homoeopathic Medical College and Hospital 2. Central Reseach Institute of Homeopathy |
Bakson Homoeopathic Medical College & Hospital,Greater Noida,Uttar Pradesh Greater Noida,Uttar Pradesh Gautam Buddha Nagar UTTAR PRADESH 201306 India
Gautam Buddha Nagar
UTTAR PRADESH |
8763513153
subhranshuprabha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IECHS |
Approved |
| IECHS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K599||Functional intestinal disorder, unspecified, (2) ICD-10 Condition: K582||Mixed irritable bowel syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Indivisualised homoeopathic medicines will be given orally depending up on indivisual case . |
Indivisualised homoeopathic medicines will be given orally depending up on indivisual case . |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of both sexes irrespective of socioechonomic status having clinical features (signs & symptoms) of irritable bowel syndrome satisfying Rome IV criteria
2.age 18-50 yrs
3.pts who have score more then zero in perceived stress scale
4.patients willing to give consent for the study |
|
| ExclusionCriteria |
| Details |
1.patients who have a score of zero in perceived stress scale
2.patients having clinical features of weight loss ,bleeding per rectum ,persistant diarrhoea will be excluded.
3.pts having diseases like celiac disease, IBD, lactose malabsorption etc
4.patients having abnormal findings in lab investigation like low HB ,Presence of microorganisms in stool etc.
5. pt with advanced systemic diseases ,DM, HTN ,Thyroid disorders
6.pts having allopathic treatment and hospitalised treatment failure
7.pregnant and lactating females
8.patients without proper follow up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in IBS Symptom severity scale and perceived stress scale |
change in IBS Symptom severity scale and perceived stress scale at baseline and after every four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
07/12/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/12/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To identify the role of homoeopathy in Irritable bowel syndrome by improvement in symptom severity and intensity via IBS SSS.( SYMPTOM SEVERITY SCALE ). To assess the levels of stress by perceived stress scale response and number of sick days per month due to comorbid conditions and/or acute illness episodes. |