| CTRI Number |
CTRI/2025/11/097134 [Registered on: 10/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicine in chronic migraine. |
|
Scientific Title of Study
|
The effectiveness of individualized homoeopathic treatment on chronic migraine associated with stress and anxiety using MIDAS scale :
an open label, prospective, clinical study |
| 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 BONELA SIRISHA |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD 24 Department of practice of medicine National Institute of Homoeopathy GE Block Sector 3 Salt lake kolkata 700106 West Bengal India
Kolkata
WEST BENGAL
700106
India |
| Phone |
6300367247 |
| Fax |
|
| Email |
sirishathallibonela001@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF. (DR.) GAUTAM PAL |
| Designation |
PROFESSOR, HEAD OF THE DEPARTMENT |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD 24 Department of practice of medicine National Institute of Homoeopathy GE Block Sector 3 Salt lake kolkata 700106 West Bengal India
Kolkata
WEST BENGAL
700106
India |
| Phone |
9433902556 |
| Fax |
|
| Email |
drgautampal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BONELA SIRISHA |
| Designation |
POST GRADUATE TRAINEE |
| Affiliation |
National Institute of Homoeopathy |
| Address |
OPD 24 Department of practice of medicine National Institute of Homoeopathy GE Block Sector 3 Salt lake kolkata 700106 West Bengal India
Kolkata
WEST BENGAL
700106
India |
| Phone |
6300367247 |
| Fax |
|
| Email |
sirishathallibonela001@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD 24 Department of practice of medicine National Institute of Homoeopathy GE Block Sector 3 Salt lake kolkata 700106 West Bengal India |
|
|
Primary Sponsor
|
| Name |
National Institute of Homoeopathy |
| Address |
Block GE, Sector 3, Salt lake , Kolkata, 700106. |
| 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 |
| DR BONELA SIRISHA |
National Institute of Homoeopathy |
OPD 24 Department of practice of medicine National Institute of Homoeopathy GE Block Sector 3 Salt lake kolkata 700106 West Bengal India
Kolkata
WEST BENGAL |
6300367247
sirishathallibonela001@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: G43||Migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homoeopathic Medicine. |
Individualized Homoeopathic Medicine will be given based on case taking for every patient for a period of 6months and potency repetition will be done according to the principles of homoeopathy. Data will be collected at base line , 3rd month and 6th month. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants who are diagnosed with chronic migraine according to ICHD – 3 criteria.
Participants diagnosed with chronic migraine with stress or anxiety or both.
Participants of age between 18 to 50 years of age.
Participants who are willing to participate with informed consent in the study.
Participants who can able to understand and communicate.
|
|
| ExclusionCriteria |
| Details |
Participants who are diagnosed with an unstable mental or psychiatric illness.
Participants suffering from serious systematic disorders or life-threatening diseases.
Pregnant or lactating women.
Migraine due to estrogen based hormonal therapeutics like oral contraceptive pills (OCPs), hormonal replacement therapy (HRT).
Immune-compromised diseased conditions.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| MIDAS scale |
Base line, 3rd month, 6th month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PSS-14
BAI-21 |
Base line, 3rd month, 6th month. |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
21/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This clinical study will evaluate the effectiveness of individualized homoeopathic treatment in individuals diagnosed with chronic migraine (ICD-11 code: 8A80.2) and emotional symptoms such as anxiety and depression. The study will span 1 year and 6 months, with monthly follow-ups. Evaluations will be conducted at baseline, 3rd month, and 6th month using standardized tools: MIDAS (Migraine Disability Assessment), PSS (Perceived Stress Scale), and BAI (Beck Anxiety Inventory). Participants will be selected based on defined inclusion and exclusion criteria, and informed consent will be obtained prior to enrollment. |