| CTRI Number |
CTRI/2024/11/077035 [Registered on: 19/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Other (Specify) [Therapeutic effectiveness] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effects of Iris Versicolor over Individualized Homoeopathic Medicines in patients suffering from Migraine |
|
Scientific Title of Study
|
Evaluating the effectiveness of Individualized Homoeopathic Medicines vs Iris Versicolor in treatment of Migraine: A randomised controlled clinical 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 Manisha Gairola |
| Designation |
PG Scholar |
| Affiliation |
Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Delhi-110021 |
| Address |
Department of Homoeopathic Materia Medica, 3rd floor, Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi-110021
South West
DELHI
110021
India |
| Phone |
8802646077 |
| Fax |
|
| Email |
manisha94gairola@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr U Rajeev Nair |
| Designation |
Professor and HOD, Department of Homoeopathic Materia Medica |
| Affiliation |
Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre |
| Address |
Department of Homoeopathic Materia Medica, Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Motibagh, Nanakpura, New Delhi-110021
South West
DELHI
110021
India |
| Phone |
9868393285 |
| Fax |
|
| Email |
drrajivh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manisha Gairola |
| Designation |
PG Scholar |
| Affiliation |
Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Delhi-110021 |
| Address |
Department of Homoeopathic Materia Medica, 3rd floor, Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi-110021
South West
DELHI
110021
India |
| Phone |
8802646077 |
| Fax |
|
| Email |
manisha94gairola@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi- 110021, India |
|
|
Primary Sponsor
|
| Name |
Dr Manisha Gairola |
| Address |
Department of Materia Medica, 3rd floor, Dr B. R. Sur, Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi-110021, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Manisha Gairola |
Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre |
OPD and IPD of Dr. B.R. Sur Homoeopathic Medical College, Hospital and Research Centre, Nanakpura, Motibagh, New Delhi-110021, India
South West
DELHI |
8802646077
manisha94gairola@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee(IEC), DR BR SUR HOMOEOPATHIC MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTRE, DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G43||Migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Individualized Homoeopathic Medicine |
Individualized Homoeopathic Medicines will be administered in centesimal potencies, selected according to homoeopathic principles. The dose and repetition will be adjusted as per the requirement of each case.
Route of administration- Oral, in globules form.
Duration: 6 months |
| Intervention |
Iris Versicolor |
Iris Versicolor will be administered in centesimal potencies, selected according to homoeopathic principles. The dose and repetition will be adjusted as per the requirement of each case.
Route of administration- Oral, in globules form.
Duration: for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Both sexes of age group 18-60 years, irrespective of their race, caste, religion and socioeconomic status. 2.Patients presenting with symptoms of migraine according to International Classification of Headache Disorder 3rd edition (ICHD-III). |
|
| ExclusionCriteria |
| Details |
1. Patients suffering with any cause of secondary headache like trauma, metabolic or vascular disorders, non-vascular intracranial lesions, abuse of alcohol or other psychoactive substances.
2. Pregnant and lactating mothers.
3. Migraine patients suffering from any life-threatening complication.
4. Patients with history of cerebral-vascular accident, convulsions, severe coronary disease, uncontrolled hypertension, and malignancy.
5. Patients with psychiatric comorbidities.
6. Unwilling to take part and not giving consent to join the study or unable to read the patient information sheet. Patients unable to comply with study protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effectiveness of Individualized Homoeopathic Medicines vs Iris versicolor in reducing the intensity(VAS) and frequency(attacks per month) of Migraine among the participants.
|
The Visual Analog Scale (VAS) for pain will be measured at baseline and then at every 2 weeks, till 6 months(24th week) of treatment while the frequency of migraine attacks will be recorded at baseline and then at every 4 weeks, till 6 months(24th week) of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of Individualized Homoeopathic Medicines compared to Iris versicolor on migraine-related disability using the Migraine Disability Assessment (MIDAS) score as the outcome measure. |
The Migraine Disability Assessment (MIDAS) will be evaluated twice in this study. First at baseline & then after six months(24th week) of treatment.
|
|
|
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 3 |
|
Date of First Enrollment (India)
|
29/11/2024 |
| 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="1"
Months="0"
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
|
This study is a Randomized controlled clinical trial involving patients aged 18 to 60 years who present with migraine symptoms, as defined by the International Classification of Headache Disorders, 3rd edition (ICHD-III). Participants will be divided into two groups through randomization. One group will receive Individualized homeopathic remedy, while the other group will be administered Iris Versicolor. The potency, dosage and repetition of the medicines will be determined on the basis of the requirement of case, following the homeopathic principles. Participants will be followed up every two weeks, with assessments conducted at each visit. The Visual Analog Scale (VAS) for pain will be measured at every 2 weeks, while the frequency of migraine attacks will be recorded monthly. The Migraine Disability Assessment (MIDAS) will be evaluated at baseline and after six months of treatment. Each case will be observed for a minimum period of six months, and the data collected at the end of this period will be statistically analyzed and interpreted in comparison to baseline values to draw inferences.
|