| CTRI Number |
CTRI/2024/05/068110 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
02/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Usefulness of medicines from Ranunculaceae family in cases of Migraine |
|
Scientific Title of Study
|
Utility of remedies from Ranunculaceae family in cases of Migraine |
| 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 Jigar Parikh |
| Designation |
PG Scholar |
| Affiliation |
SMT A J Savala Homoeopathic medcal college and research institute Mehsana Gujarat |
| Address |
Room no 10 department of medicine opd ground floor Smt A J Savala Homoeopathic Medical College and Research institute Pushpanjali building near district session court mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9825714796 |
| Fax |
- |
| Email |
parikhjigar5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Trivedi |
| Designation |
PROFESSOR |
| Affiliation |
SMT A J Savala Homoeopathic medcal college and research institute Mehsana Gujarat |
| Address |
PG Department of Homoeopathic materia medica Smt A J Savala Homoeopathic Medical College and Research institute Pushpanjali building near district session court mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9974342824 |
| Fax |
- |
| Email |
nisha.mehul26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigar Parikh |
| Designation |
PG Scholar |
| Affiliation |
SMT A J Savala Homoeopathic medcal college and research institute Mehsana Gujarat |
| Address |
Room no 10 department of medicine opd ground floor Smt A J Savala Homoeopathic Medical College and Research institute Pushpanjali building near district session court mehsana
Mahesana
GUJARAT
384001
India |
| Phone |
9825714796 |
| Fax |
- |
| Email |
parikhjigar5@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt a j savla homoeopathic medical college and research institute Pushpanjali building near district session court mehsana |
|
|
Primary Sponsor
|
| Name |
Dr jigar Parikh |
| Address |
Room no 10 department of medicine opd ground floor Smt A J Savala Homoeopathic Medical College and Research institute Pushpanjali building near district session court mehsana |
| 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 jigar parikh |
SMT A J savala Homoeopathic medical college and reaserch institute |
Room no 10 department of medicine opd ground floor Smt A J Savala Homoeopathic Medical College and Research institute Pushpanjali building near district session court mehsana
Mahesana
GUJARAT |
9825714796
-
parikhjigar5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMT A J Savala Homoeopathc medical college 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 |
Homoeopathic medicines from RANUNCULACEAE family
|
Potency various decimal centesimal fifty millesimal
Dose as per requirement of case
Frequency as per requirement of case
Route of Administration oral
Duration of therapy up to 8 months as per need of case
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Already diagnosed cases of migraine
Age group: 12 – 65 years
Sex: Male, Female and Transgender
Pain severity more than 5 on eleven-point pain scale
MIDAS disability score less than 20
|
|
| ExclusionCriteria |
| Details |
Co morbid gross pathology of CNS
Severe disability or equal to 20 on MIDAS
Pregnancy and lactating female
Patients who are not able to fill Eleven point pain scale and MIDAS
Status migrainosus persistent aura without infarction migrainosus infarction and migraine aura triggered seizure
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Eleven – point pain scale |
data will be taken at baseline and at end of treatment of eight months of duration to assess changes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MIDAS score |
Data will be taken at baseline of treatment and at end of treatment of eight months of
duration to assess changes |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
13/06/2024 |
| Date of Study Completion (India) |
05/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
05/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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 Prospective pretest posttest
interventional trial UTILITY OF
REMEDIES FROM RANUNCULACEAE FAMILY IN CASES OF MIGRAINE as per inclusion and
exclusion criteria from outpatient department 40 participants will be selected
by non-probability sampling outcome will be measured by assessment of Eleven
– point pain scale and MIDAS score at
baseline and at end of treatment |