| CTRI Number |
CTRI/2024/05/067864 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
21/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeopathy in Migraine |
|
Scientific Title of Study
|
A Prospective Study Homoeopathic Management in cases of Migraine with its Miasmatic Evaluation |
| 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 Shreya Kailashkumar Mehta |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine & Homoeopathic Philosophy, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9426518429 |
| Fax |
|
| Email |
shreyamehta2791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saunil Malvania |
| Designation |
Professor |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine & Homoeopathic Philosophy, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9825416487 |
| Fax |
|
| Email |
saunil.malvania23663@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Kailashkumar Mehta |
| Designation |
PG Scholar |
| Affiliation |
Rajkot Homoeopathic Medical College |
| Address |
Department of Organon of Medicine & Homoeopathic Philosophy, Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Rajkot.
Rajkot
GUJARAT
360002
India |
| Phone |
9426518429 |
| Fax |
|
| Email |
shreyamehta2791@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajkot Homoeopathic Medical College, behind Jaynath Complex, Makkam chowk, Rajkot-360002, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Rajkot Homoeopathic Medical College |
| Address |
Rajkot Homoeopathic Medical College, Behind Jaynath Complex, Makkam chowk, Rajkot- 360002, Gujarat, 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 |
| Dr Shreya Kailashkumar Mehta |
Rajkot Homoeopathic Medical College |
102, Department of Organon of Medicine & Homoeopathic philosophy. Rajkot Homoeopathic Medical College, Behind Jaynath complex, Makkam chowk, Rajkot-360002, Gujarat, India.
Rajkot
GUJARAT |
9426518429
shreyamehta2791@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Research- Rajkot Homoeopathic Medical College(RHMC), Parul University, Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G43D||Abdominal migraine, (2) ICD-10 Condition: G437||Chronic migraine without aura, (3) ICD-10 Condition: G43A||Cyclical vomiting, (4) ICD-10 Condition: G434||Hemiplegic migraine, (5) ICD-10 Condition: G431||Migraine with aura, (6) ICD-10 Condition: G430||Migraine without aura, (7) ICD-10 Condition: G43B||Ophthalmoplegic migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine with the use of Miasmatic understanding. |
Individualised Homoeopathic Medicine selected with the help of miasmatic understanding in cases of Migraine. Mode of administration: Oral(Sublingual). Selection of potency, dose & repetition: Individualised homeopathic medicine will be prescribed in 30, 200, 1M potency. Selection of dosage, potency & repetition will be according to susceptibility of patient & principles of Organon of Medicine. The total duration of intervention is 9 months. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Cases of age group: 10-50 years
Gender: male & female
Pre-diagnosed cases of migraine or new cases. fulfilling diagnostic criteria (ICHD-3); based on clinical history. |
|
| ExclusionCriteria |
| Details |
Age below 10 and more than 50 years.
Patients needing emergency medical intervention or with complications of migraine.
Patients with other type of primary or secondary headache & other terminal disease.
Patients who are on other therapeutic measures of other disciplines for migraine.
Patients on any long term allopathic treatment which can interfere with Migraine treatment.
Pregnant lady. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
For the effective assessment and evaluation,
disease intensity scores will also be
maintained according to MIDAS Score.
|
After the intervention, the first follow-up will take
place in 15 days, followed by subsequent
follow-ups every 15 days. Assessment score will be done every 3 months. There will be some improvement after prescribing the Homoeopathic Medicines using miasmatic understanding.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical improvement - reduction in intensity of complains, improvement in general health & increase in productivity of patient.
.
|
There will be some improvement after prescribing Homoeopathic medicines on basis of miasmatic evaluation, noticeable during the first follow-up after 15 days. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
05/06/2024 |
| 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="0"
Months="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Migraine is a genetically influenced complex disorder characterized by episodes of moderate-to-severe headache, most often unilateral and generally associated with nausea and light and sound sensitivity. Over the past three decades, migraine prevalence has significantly increased worldwide. The projected global prevalence of migraine grew from 721.9 million in 1990 to 1.1 billion in 2019, according to the Global Burden of Disease (GBD) 2019 study. With 12% of the population affected, migraines can strike up to 17% of women and 6% of men annually. It accounts for 3% of all emergency visits annually and is consistently the fourth or fifth most frequent reason for visits. In India, the prevalence of migraine is progressively rising. In India, migraines were shown to affect over 213 million individuals in 2019. The drug classes that are most frequently used to treat migraine attacks are those that are specific to the condition, like triptans and ergot alkaloids and derivatives, as well as non-specific ones, like nonsteroidal anti-inflammatory drugs (NSAIDs), barbiturates, combination analgesics, and antiemetics. Each class of drugs comes with drawbacks and side effects of its own. Homoeopathic practice follows the Law of Similia where a physician has to understand the man as a whole. The one-size-fits-all methods of conventional treatment are in contrast to this customized approach. The specific requirements of every migraine sufferer might not be met by generic medicines. Homeopathy not only relieves the pain but also reduces the recurrence of migraine. Hahnemann used the term miasma to refer to the morbific factors linked to the development of diseases, which literally translates to any noxious emanation or effluvia or polluting factor. According to Hahnemann, miasm also includes the abnormal susceptibility of individuals for certain acute & chronic disease where the cause of the disease is endogenous. Understanding the miasmatic background of a patient is believed to help prescribe remedies that address the individual’s underlying state of health. |