| CTRI Number |
CTRI/2020/10/028621 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
29/10/2020 |
| 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 headache |
|
Scientific Title of Study
|
Individualized homoeopathic medicines in treatment of chronic migraine: Double-blind, randomized, placebo-controlled, pilot trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1259-4426 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanaya Chanda |
| Designation |
Postgraduate Trainee |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD room no 12; 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
8240167620 |
| Fax |
|
| Email |
tanayachanda77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Rajat Chattopadhyay |
| Designation |
Principal |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD room no 12; 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Rajat Chattopadhyay |
| Designation |
Principal |
| Affiliation |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
Department of Practice of Medicine; OPD room no 12; 265, 266, Acharya Prafulla Chandra Road, Kolkata 700009
Kolkata
WEST BENGAL
700009
India |
| Phone |
9331041142 |
| Fax |
|
| Email |
dr.rajatchatterjee@gmail.com |
|
|
Source of Monetary or Material Support
|
| The Calcutta Homoeopathic Medical College and Hospital,
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal |
|
|
Primary Sponsor
|
| Name |
The Calcutta Homoeopathic Medical College and Hospital |
| Address |
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal |
| 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 |
| Tanaya Chanda |
The Calcutta Homoeopathic Medical College and Hospital |
265, 266, Acharya Prafulla Chandra Road, Kolkata 700009, West Bengal
Kolkata
WEST BENGAL |
8240167620
tanayachanda77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies, as decided appropriate to the case or condition. In centesimal scale, each dose shall consist of 4 globules (no. 30) of cane sugar, medicated with the indicated medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with 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. All medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. Each patients will be given general advices on lifestyle management by controlling trigger factors, like maintaining regularity of regimen with regard to meals, hydration, sleep; counselling for reduction of stress, depression and anxiety, postural corrections, reducing caffeine overuse, and daily supplementation of riboflavin 400 mg/day. Duration of therapy: 3 months. |
| Comparator Agent |
Placebo |
This arm will receive placebo, indistinguishable in appearance from verum. Each dose of placebo shall consist of 4 globules (no. 30) of cane sugar, moistened with rectified spirit, to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Each patients will be given general advices on lifestyle management by controlling trigger factors, like maintaining regularity of regimen with regard to meals, hydration, sleep; counselling for reduction of stress, depression and anxiety, postural corrections, reducing caffeine overuse, and daily supplementation of riboflavin 400 mg/day. Duration of therapy: 3 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from chronic migraine, that is, headache on 15 or more days/month for more than 3 months, with a feature of migraine headache on at least 8 days/month (ICD-10-CM Code G43.709)
2. Patients of 18-65 years of age and of either sex
3. Patients who have not taken any treatment since at least 2 weeks for migraine
4. Literate patients; can read Bengali and/or English
5. Providing written informed consent to participate in the trial |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from the complications of migraine
2. Patients who are undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), antiemetic, or oestrogen during 2 weeks prior to enrolment in the study
3. Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life
4. Patients who are too sick for consultation
5. Pregnant and puerperal women, and lactating mothers
6. Substance abuse and/or dependence
7. Self-reported immune-compromised state
8. Undergoing homoeopathic treatment for any chronic disease within last 6 months. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Monthly migraine days (MMD) |
At baseline, every month, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Migraine Disability Assessment Test (MIDAS) scores |
At baseline, every month, up to 3 months |
| EQ-5D-5L scores |
At baseline, every month, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
26/10/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet; to be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Migraine is defined as ‘headache occurring on ≥15 days/month for > 3 months with features of migraine on ≥8 days/months. Presenting symptoms include throbbing pain either one-sided (usually) or bilateral, aggravated on least movement, associated with nausea, dizziness, extreme sensitivity to lights, noises, smell, lack of appetite, bowel disturbances and visual or sensory aura. It is included among top 40 conditions, which cause worldwide disability and it produces 3.63 times greater disability. Recent studies showed about 8.4% of Indian population is suffering from chronic migraine. There was no study conducted in past 10 yrs in homoeopathy on migraine. In this double-blind, randomized, placebo-controlled trial at The Calcutta Homoeopathic Medical College and Hospital, 60 patients suffering from chronic migraine will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical looking placebo (control; n=30). We aim to examine whether there are any differences in outcomes between these two groups over 3 months of intervention. Monthly migraine days (MMD) scores, Migraine Disability Assessment Test (MIDAS) scores and EQ-5D-5L scores will be used as the primary and secondary outcome measures respectively, measured at baeline and every month up to 3 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals. |