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CTRI Number  CTRI/2026/01/102358 [Registered on: 28/01/2026] Trial Registered Prospectively
Last Modified On: 28/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   A clinical trial of natrum muriaticum in centesimal potencies versus individualized homoeopathic medicine in chronic migraine 
Scientific Title of Study   Comparative study of physicochemical profiles of natrum muriaticum 3x trituration and tablet prepared manually and mechanically and a pilot open-label non-randomized clinical trial of natrum muriaticum in centesimal potencies versus individualized homoeopathy in chronic migraine 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1334-4180  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Subhashree Modak 
Designation  Post graduate trainee 
Affiliation  The Culcutta Homoeopathic Medical College and Hospital 
Address  Room no. 18,Dept. of Homoeopathic Pharmacy, The Culcutta Homoeopathic Medical College and Hospital, 265,266 APC Road, Kolkata West Bengal, India,700009

Kolkata
WEST BENGAL
700009
India 
Phone  8617283954  
Fax    
Email  subhashree.modak.sm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Kaushik Deb Das 
Designation  Principal-in-charge and administrator 
Affiliation  The Culcutta Homoeopathic Medical College and Hospital 
Address  Room no. 18,Dept. of Homoeopathic Pharmacy, The Culcutta Homoeopathic Medical College and Hospital, 265,266 APC Road, Kolkata West Bengal, India,700009

Kolkata
WEST BENGAL
700009
India 
Phone  9932298682  
Fax    
Email  drkaushikddas25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Kaushik Deb Das 
Designation  Principal-in-charge and administrator 
Affiliation  The Culcutta Homoeopathic Medical College and Hospital 
Address  Room no. 18,Dept. of Homoeopathic Pharmacy, The Culcutta Homoeopathic Medical College and Hospital, 265,266 APC Road, Kolkata West Bengal, India,700009


WEST BENGAL
700009
India 
Phone  9932298682  
Fax    
Email  drkaushikddas25@gmail.com  
 
Source of Monetary or Material Support  
The Culcutta Homoeopathic Medical College and Hospital,Room no. 18, Dept. of Homoeopathic Pharmacy, 265-266, APC Road, Kolkata, West Bengal, 700009 
 
Primary Sponsor  
Name  Subhashree Modak 
Address  Room no. 18, Dept. of Homoeopathic Pharmacy, 265-266, APC Road, Kolkata, West Bengal, 700009 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Subhashree Modak  The Calcutta Homoeopathic Medical College and Hospital  Room no. 18, Dept. of Homoeopathic Pharmacy, 265-266, APC Road, Kolkata, West Bengal, India, 700009
Kolkata
WEST BENGAL 		 8617283954

subhashree.modak.sm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of The Calcutta Homoeopathic Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G437||Chronic migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Individualized Homoeopathic Medicine  Individualized Homoeopathic Medicine will be prescribed at baseline and followed up each month for next three months 
Intervention  Natrium muriaticum in centesimal potency  Medicine will be prescribed at baseline and followed up each month for next three months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adults aged between 18 and 60 years.
A clinical diagnosis of chronic migraine, defined as headache occurring on 15 or more days per month for a duration of at least three consecutive months. On at least 8 days/month, the headache should fulfill criteria for migraine without aura (1.1), or respond to migraine-specific treatment (e.g., triptans, ergot derivatives)., in accordance with the International Classification of Headache Disorders, 3rd edition (ICHD-3).
MIDAS score is greater than or equal to 6.
Willingness to provide written informed consent and comply with study procedures.
Not taking any other homeopathic treatment during the study period.
Willing to report and refrain from starting new allopathic or alternative interventions for migraine during the study. 
 
ExclusionCriteria 
Details  Presence of a secondary headache disorder (e.g., attributed to trauma, vascular disorders, intracranial neoplasms, infections, substance use/withdrawal, or psychiatric illness, as defined by ICHD-3 (e.g., code 6–12).
Other Primary Headache Disorders: Diagnosed with cluster headache, chronic tension-type headache without migraine features, medication overuse headache, or hemiplegic/basilar migraine.
Severe Uncontrolled Comorbidities: Uncontrolled hypertension, diabetes mellitus, renal, hepatic, or cardiac diseases that may interfere with study outcomes.
Coexisting severe psychiatric conditions (such as History of major depression, bipolar disorder, or schizophrenia etc.) that may interfere with assessment.
Pregnancy or lactation.
Use of ongoing prophylactic headache medication that cannot be safely discontinued.
Unwillingness to adhere to study protocol or provide written informed consent.
Concurrent enrollment in another clinical trial within the last 3 months. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Migraine Disability Assessment Scale (MIDAS) to assess impact on daily functioning  At baseline and three months 
 
Secondary Outcome  
Outcome  TimePoints 
Visual Analogue Scale (VAS) for headache intensity.
Frequency of chronic headache attacks (monthly). 		 At baseline and three months 
 
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)   09/02/2026 
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   Chronic migraine is a disabling primary headache disorder, defined by the International Classification of Headache Disorders, 3rd edition (ICHD-3), as a headache occurring on 15 or more days per month for more than three consecutive months, of which at least eight days per month must involve migraine features such as throbbing pain, photophobia, phonophobia, or nausea and/or vomiting. The objective of the trial is to compare the therapeutic efficacy of Natrum muriaticum in centesimal potencies with individualized homoeopathic prescriptions in patients suffering from chronic migraine in a pilot open-label quasi-experimental study. The primary assessment tool is Migraine Disability Assessment Scale (MIDAS) to assess impact on daily functioning and the secondary assessment tools are Visual Analogue Scale (VAS) for headache intensity and frequency of chronic headache  attacks. All the assessments are done at the baseline and after three months. 
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