CTRI Number |
CTRI/2022/07/044049 [Registered on: 15/07/2022] Trial Registered Prospectively |
Last Modified On: |
12/07/2022 |
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 Migraine |
Scientific Title of Study
|
Efficacy of Individualized Homoeopathic Medicines for Migraine among adults; Double blind, Randomized, Placebo controlled Clinical Trial |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
U1111-1280-0725 |
UTN |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Hanuman Ram |
Designation |
PhD Scholar |
Affiliation |
Homoeopathy University, Jaipur, Rajasthan |
Address |
Dr M.P.K. Homoeopathic Medical College, Hospital and Research Center, Homoeopathy University, Saipura, Sanganer, Jaipur, Rajasthan.
Jaipur RAJASTHAN 302029 India |
Phone |
9462279933 |
Fax |
|
Email |
drhrchoudhary@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Sonia Tuteja |
Designation |
Professor, Dept. of Homoeopathic Materia Medica |
Affiliation |
Homoeopathy University, Jaipur, Rajasthan |
Address |
Dr M.P.K. Homoeopathic Medical College, Hospital and Research Center, Homoeopathy University, Saipura, Sanganer, Jaipur, Rajasthan.
Jaipur RAJASTHAN 302029 India |
Phone |
9530454132 |
Fax |
|
Email |
drsoniatuteja@yahoo.in |
|
Details of Contact Person Public Query
|
Name |
Dr Hanuman Ram |
Designation |
PhD Scholar |
Affiliation |
Homoeopathy University, Jaipur, Rajasthan |
Address |
Dr M.P.K. Homoeopathic Medical College, Hospital and Research Center, Homoeopathy University, Saipura, Sanganer, Jaipur, Rajasthan.
RAJASTHAN 302029 India |
Phone |
9462279933 |
Fax |
|
Email |
drhrchoudhary@gmail.com |
|
Source of Monetary or Material Support
|
Madhav Homoeopathic Medical College and Hospital, Abu Road, Rajasthan. |
|
Primary Sponsor
|
Name |
None |
Address |
Nil |
Type of Sponsor |
Other [NA] |
|
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 |
Dr Hanuman Ram |
Madhav Homoeopathic Medical College and Hospital |
Department of Homoeopathic Materia Medica, Madhav Homoeopathic Medical College and Hospital, Madhav Hills, Opp. Banas River Bridge Toll N.H. 27, P.O. Bharja, Abu Road, Rajasthan 307026. Sirohi RAJASTHAN |
9462279933
drhrchoudhary@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee of Homoeopathy University, Jaipur, Rajasthan |
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 |
Administration of indicated homoeopathic medicines in centesimal potencies as per the need of the patient and as decided appropriate by the investigator. Each dose of centesimal scale consisted of 4 cane sugar globules no. 30 medicated with the indicated medicine (preserved in 90% v/v ethanol), orally on a clean tongue. The dosage and repetition depending upon the individual requirement of the case. The duration of treatment for each subject will be 06 months. All medicines will be procured from a Good Manufacturing Practice-certified firm. Final selection of the single individualized medicine and dosage will be in accordance with standard homoeopathic guidelines. The prescriptions on follow-up visits will be generated as per relevant homoeopathic principles and recorded in follow-up sheets. Homoeopathic prescriptions may be changed during the study as and when required in adherence with homoeopathic principles.
Each patient will be given general advices on lifestyle management by controlling trigger factors, like maintaining regularity of regimen with regard to meals, psychological counseling for reduction of stress, depression and anxiety, regular physical exercise and wake-sleep habits, and maintenance of headache diary to enhance awareness of events that bring on headache. |
Comparator Agent |
Placebo |
Placebo will be identical in appearance with and indistinguishable from the medicine. Each dose of placebo shall consist of 4 cane sugar globules no. 30 moistened with rectified spirit, to be taken orally on clean tongue. The dosage and repetition depending upon the individual requirement of the case. The duration of treatment for each subject will be 06 months. Each patient will be given general advices on lifestyle management by controlling trigger factors, like maintaining regularity of regimen with regard to meals, psychological counseling for reduction of stress, depression and anxiety, regular physical exercise and wake-sleep habits, and maintenance of headache diary to enhance awareness of events that bring on headache. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Subjects who has diagnosed as per the International classification of Headache disorders diagnostic criteria - 3 for Migraine.
2. Subjects will be selected irrespective of their sex, socio-economic status and occupation.
3. Age between 18 to 50 years.
4. If the subject is illiterate then the relatives or family members will be assessed to fill the headache diary.
5. Subjects who are willing to participate and sign the written informed consent form.
|
|
ExclusionCriteria |
Details |
1. Subjects suffering from the complications of migraine.
2. Suspected secondary headache (trauma, headache attributed to vascular or non vascular intracranial disorders, medication overuse headache, hypertension).
3. Subjects are undergoing treatment with non-steroidal anti inflammatory drugs (NSAIDS), antiemetic, triptans, ergot alkaloids and oestrogen during 2 weeks prior to enrollment in the study.
4. Subjects suffering from uncontrolled systemic illness or psychiatric diseases and/or life-threatening infections.
5. Substance abuse and/or dependence.
6. Pregnant or lactating women.
7. Subjects already undergoing homoeopathic treatment elsewhere for any chronic disease within last 02 months.
8. Non-compliance to the study treatment/ protocol.
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
Method of Concealment
|
Pre-numbered or coded identical Containers |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Diagnostic Headache Diary (DHD) |
Baseline, every month, up to 6 months |
|
Secondary Outcome
|
Outcome |
TimePoints |
Migraine Disability Assessment Questionnaire (MIDAS) |
Baseline, 3 months, 6 months |
EQ-5D-5L and EQ-VAS Questionnaire |
Baseline, 3 month, 6 months |
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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)
|
18/07/2022 |
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
|
None yet; to be published
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Migraine is a common disabling primary headache disorder. Previous epidemiological studies have documented its high prevalence and socio-economic and personal impact in quality of life of an individual. It affects ~15% of the population, during the formative and most productive periods of their lives between the ages of 22 and 55 years. In the Global Burden of Diseases (GBD) 2010, it was ranked as the third most prevalent disorder in the world. In GBD 2015, it was ranked the third-highest cause of disability worldwide in both males and females under the age of 50 years. Patient suffering as well as recommendations to start conventional medication early have resulted in headaches from medication overuse, which is a major health problem (not in the least from the side-effects) with a prevalence of about 1%. However, the conventional treatment are not always fully effective and some have marked adverse effects. Because of this, many patients suffering from migraine may try alternative therapies such as homeopathy. Homeopathy may hold promise in successful treatment of migraine, but has remained under/poor researched. In this double-blind, randomized, placebo-controlled, clinical trial at Madhav Homoeopathic medical college and hospital, Abu road, Rajasthan 86 patients will be randomized to either individualized homoeopathic medicines or placebo to examine whether individualized homoeopathic medicines have any different effect from placebo in treatment of migraine. The frequency, duration and intensity of migraine attack will be assessed at baseline, every month and up to the 06 month by Diagnostic Headache Diary (DHD). The Migraine disability and quality of life of patients will be assessed at baseline, 03 months and after 06 months by Migraine Disability Assessment Questionnaire (MIDAS), EQ-5D-5L and EQ-VAS Questionnaire scores. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals. |