| CTRI Number |
CTRI/2023/07/055495 [Registered on: 21/07/2023] Trial Registered Prospectively |
| Last Modified On: |
20/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of Chronic Functional Constipation in adults |
|
Scientific Title of Study
|
The Efficacy of Individualized Homoeopathic Medicines in Centesimal Potency
in the Treatment of Chronic Functional Constipation in Adults: A Double-Blind,
Randomized, Placebo-Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1292-7967 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAYBA KHATOON |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Special OPD (Room no.
14), Medicine OPD (Room no. 12), 265,266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India
Kolkata
WEST BENGAL
700009
India |
| Phone |
7001849780 |
| Fax |
|
| Email |
raybakhatoon24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
HIMANGSU HAIT |
| Designation |
MD (Homoeopathy) PhD Professor, HOD (Practice of Medicine) |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Special OPD (Room no.
14), Medicine OPD (Room no. 12), 265,266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
haitdrhimangsu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
HIMANGSU HAIT |
| Designation |
MD (Homoeopathy) PhD Professor, HOD (Practice of Medicine) |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine, Special OPD (Room no.
14), Medicine OPD (Room no. 12), 265,266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India
Kolkata
WEST BENGAL
700009
India |
| Phone |
9433565680 |
| Fax |
|
| Email |
haitdrhimangsu@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College & Hospital, 265, 266 Acharya Prafulla Chandra
Road, Kolkata 700009 |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009 |
| Type of Sponsor |
Government 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 |
| RAYBA KHATOON |
The Calcutta Homoeopathic Medical College and Hospital |
Department of Practice of Medicine, Special OPD (Room no.
14), Medicine OPD (Room no. 12), 265,266 Acharya Prafulla Chandra Road
Kolkata
WEST BENGAL
700009
India
Kolkata
WEST BENGAL |
7001849780
raybakhatoon24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Calcutta Homoeopathic Medical College and Hospital Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebo with
concomitant care
|
This group will receive placebo, identical in appearance
with the verum. Each dose will consist of 4 cane sugar globules no. 40 moistened with
90% v/v ethanol, to be taken orally on clean tongue in empty stomach; dosage and
repetition will be maintained depending upon the individual requirement of the cases.
All sundry items will be procured from a Good Manufacturing Practice (GMP) certified
firm. Duration of therapy: 3months. Both medicines and placebos will be re-packed in
identical glass bottles and labelled with code, name of medicines, potency, and will be
dispensed according to the random number list. |
| Intervention |
Individualized homeopathic
medicines in centesimal
potencies with concomitant care |
Intervention is planned as administering indicated
homoeopathic medicines in centesimal potencies (Ch) as decided to the case or
condition. Each dose will consist of 4 cane sugar globules no. 40 moistened with the
indicated medicine (preserved in 90% v/v ethanol), to be take orally on clean tongue in
empty stomach; dosage and repetition depending upon the individual requirement of the
cases. Patients will be advised to refrain from handling the globules or from eating,
drinking, smoking, or brushing teeth within 30 minutes of taking the globules and will
be asked to suck the globules rather than simply swallowing those. Single individualized
medicine will be prescribed on each occasion taking into account presenting symptoms
totality, clinical history details, constitutional features, miasmatic expressions
repertorization using HOMPATH® and RADAR® software when required with due
consultation of Materia Medica and due consensus among three homoeopaths. All the
medicines and sundry items will be procured from a Good Manufacturing Practice
(GMP) certified firm. Duration of therapy: 3months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients of 18-65 years age
2. The diagnosis of chronic functional constipation was based on the Rome IV Diagnostic
Questionnaire (R4DQ) criteria for adults [Appendix- 2B] which were fulfilled for the past
3 months with symptoms onset at least 6 months before diagnosis.
3. ICD-10 code K59.04 for Chronic idiopathic constipation (functional constipation)
4. Illiterate people will be interviewed by the investigators maintaining adequate privacy to
fill up the scales or questionnaires
5. Literate participant able to read and write in English, hindi or bengali
6. Participants providing with written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Criteria for irritable bowel syndrome or OIC fulfilled as per R4DQ for adults.
2. Patients taking concomitant medications which may modify bowel habits.
3. Diagnosed case of Inflammatory Bowel Disease (IBD).
4. Has a history of structural abnormality of the Gastrointestinal (GI) tract or a disease or
condition that can affect GI motility.
5. Unstable mental or psychiatric illness or other systemic diseases ( e.g., uncontrolled
hypertension, diabetes, thyroid diseases etc.) affecting quality of life or any vital organ
failure
6. Any substance abuse
7. Self-reported immune – compromised state
8. Pregnant and puerperal women, and lactating mothers.
9. Patients who are too sick for consultation
10. Simultaneous participation of any other clinical trials.
11. Undergoing homoeopathic treatment for any chronic disease within last 6 month. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Patient Assessment of Constipation
Symptoms (PAC-SYM) questionnaire |
At baseline, every two weekly, up to three months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Patient Assessment of Constipation Quality of
Life (PAC-QOL) questionnaire |
At baseline, every two weekly, up to three months |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
31/07/2023 |
| 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
|
Constipation is defined as infrequent passage of hard stools. Patients may also complain of straining, a sensation of incomplete evacuation and either perianal or abdominal discomfort. Constipation can be acute typically lasting less than 1 week, or chronic, lasting greater than 4 weeks. Chronic constipation is normally due to a primary cause, such as dietary intake (e.g. insufficient fiber), lifestyle factors (e.g. sedentary lifestyle) or disorders of rectal evacuation. Secondary causes of chronic constipation are numerous, including drugs such as opiates. The average prevalence of constipation in adults has been estimated as 16% worldwide (varies between 0.7% and 79%). There is quite lack of data available in homoeopathy in treatment of constipation. Keeping in view this lack of validated clinical trial on Chronic Functional Constipation, we aimed to evaluate effects of homoeopathic medicines beyond placebo by conducting this 3-months Double-Blind, Randomized(1:1), Placebo-Controlled Trial of individualized homeopathic medicines in centesimal potency against placebo at The Calcutta Homoeopathic Medical College & Hospital on 140 participants with chronic function constipation in adults. For Primary outcome assessment The Patient Assessment of Constipation Symptoms (PAC - SYM) questionnaire is administered, and for secondary outcome assessment The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire is taken. |