| CTRI Number |
CTRI/2025/07/090450 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
04/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study on Habb-e-Mujarrab for Relief and Safety of Migraine |
|
Scientific Title of Study
|
Clinical Study to evaluate the efficacy and safety of Habb e Mujarrab
in the management of Shaqiqa (Migraine) |
| Trial Acronym |
Migraine |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ABDUL AZIZ |
| Designation |
PG SCHOLAR |
| Affiliation |
State Takmeel ut tib college and hospital |
| Address |
State Takmeel ut tib college and hospital near ramabai railly sthal lucknow
Lucknow
UTTAR PRADESH
126002
India |
| Phone |
8982875834 |
| Fax |
|
| Email |
abdulazizzakaullah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ABDUL QADIR |
| Designation |
READER |
| Affiliation |
State Takmeel ut tib college and hospital |
| Address |
Department of Moalajat State Takmeel ut tib college and hospital near ramabai railly sthal lucknow
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
9415757169 |
| Fax |
|
| Email |
aq.ayaz5775@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gulnaz Fatima |
| Designation |
Lecturer |
| Affiliation |
STATE UNANI MEDICAL COLLEGE HIMMATGANJ PRAYAGRAJ |
| Address |
STATE UNANI MEDICAL COLLEGE HIMMATGANJ PRAYAGRAJ
Allahabad
UTTAR PRADESH
211016
India |
| Phone |
7503668599 |
| Fax |
|
| Email |
gulfatima123@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel ut tib college and hospital near ramabai railly sthal lucknow |
|
|
Primary Sponsor
|
| Name |
State Takmeel ut tib college and hospital near ramabai railly sthal lucknow |
| Address |
State Takmeel ut tib college and hospital near ramabai railly sthal lucknow |
| 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 ABDUL AZIZ |
State Takmeel ut tib collage and hospital |
Department of Moalajat STT College and Hospital Near Ramabai Rally Sthal Lucknow
Lucknow
UTTAR PRADESH |
8982875834
abdulazizzakaullah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) For Bio Medical Research State Takmeel ut tib college and hospital near ramabai railly sthal lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G430||Migraine without aura, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Habb e Mujarrab |
Elwa (Alove barbidensis) 1 gm
Chirata (Swertia chirata) 1 gm
Jaiphal (Myristrica fragrance) 2 gm
Zeera safaid (Cuminum cyminum) 3 gm
Ajmod (Apium graveolens) 3 gm
Nakchikni (Centipeda minima) 3 gm
|
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinically diagnosed based on ICHD-3 diagnostic criteria for
Migrainee
A At least five Attack fulfilling criteria B-D
B Headache attack lasting 4-72hr
C Headache has at least two of the following four characteristic:
Unilateral location
pulsating quality,
moderate or severe pain intensity,
aggravation by or causing avoidance of routine physical activity (eg, walking or
climbing stairs)
D. During headache, at least one of the following:
Nausea and vomiting
Photophobia and phonophobia
E. Exclusion of secondary cause of Headach
3. Patient willing to sign written informed consent |
|
| ExclusionCriteria |
| Details |
Participant below 18 years and above 60 years of age.
2 Non-migrationeous headache; cluster headache; chronic paroxysmal or nonparoxysmal
hemicranias
3 Patient with neuropsychiatric illness.
4 Pregnancy and lactating women.
5 Patients with systemic illness and metabolic diseases
6. Patients unsure about attending treatment schedule regularly.
7. Patients with the history of trauma and accidents.
8. Familial hemiplegic migraine |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Visual Analogue scale (VAS)
Migraine disability assessment (MIDAS)
The number of rescue medication (e.g. simple analgesic, combination analgesics,
ergotamine, triptans) taken within three months before and after the commencement of
the treatment |
15th, 30th, 45th, 60th, 75th 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
30/07/2025 |
| 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
|
Clinical Study on Habb-e-Mujarrab for Shaqiqa (Migraine)
Background: Migraine, a neurovascular disorder with unilateral headaches, nausea, and sensory sensitivities, is linked to *sue mizaj maddi* in Unani medicine. Habb-e-Mujarrab, a polyherbal Unani formulation, is evaluated for its efficacy and safety in migraine management.
Objectives: 1. Assess efficacy of Habb-e-Mujarrab (1 gm BD, oral) for Shaqiqa. 2. Evaluate its safety.
Methodology: Design Open-label, single-arm, pre-post interventional study. Setting Moalajat OPD, State Takmeel-ut-Tib College, Lucknow. Sample Size 38 patients (18–60 years), diagnosed per ICHD-3 criteria. Exclusion Non-migrainous headaches, neuropsychiatric issues, pregnancy, systemic diseases. Intervention Habb-e-Mujarrab (1 gm BD, oral) for 30 days, 60-day follow-up. Composition Elwa, Chirata, Jaiphal, Zeera Safaid, Ajmod, Nakchikni. Outcomes Efficacy Visual Analogue Scale, Migraine Disability Assessment, rescue medication use. Safety Adverse effects, haemogram, LFTs, KFTs, urine analysis, ECG. Follow-Up Days 15, 30, 45, 60, 75, 90. Study Duration**: 18 months |