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CTRI Number  CTRI/2025/08/093854 [Registered on: 28/08/2025] Trial Registered Prospectively
Last Modified On: 19/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Therapeutic Evaluation Of Drops of oil of Banafsha And Tiryaq isaba Wa Shaqiqa In The Management Of Migraine Without Aura Shaqiqa 
Scientific Title of Study   Therapeutic Evaluation Of Qatur Ravghane Banafsha And Tiryaq Isaba Wa Shaqiqa In The Management Of Migraine Without Aura Shaqiqa A Randomized Open Label Comparative 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  Aarif Baig 
Designation  MD Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH Campus kolar bypass Road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH campus kolar bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India 
Phone  9039618581  
Fax    
Email  aarifbaig28497@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arif Anees 
Designation  Reader 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH campus Kolar bypass Road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital AYUSH campus Kolar bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India 
Phone  7354297786  
Fax    
Email  arifanees110@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Aarif Baig 
Designation  MD Scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus Kolar bypass Road Bhopal Madhya Pradesh
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush campus Kolar bypass Road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India 
Phone  9039618581  
Fax    
Email  aarifbaig28497@gmail.com  
 
Source of Monetary or Material Support  
Hakim Syed Zia Ul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur 
 
Primary Sponsor  
Name  Hakim Syed Zia Ul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Zia Ul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003 
Type of Sponsor  Government medical college 
 
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 Aarif Baig  Hakim Syed Zia Ul Hasan Government Unani Medical College and hospital   OPD 7 Department of Ilaj bit Tadbeer Ground Floor Hakim Syed Zia Ul Hasan Government Unani Medical College and Hospital Bhopal
Bhopal
MADHYA PRADESH 
9039618581

aarifbaig28497@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Syed Zia Ul Hasan Government Unani 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: G430||Migraine without aura,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Qatur and Tiryaq Isaba wa Shaqiqa  Qatur Instill Ravghane Banafsha Marketed formulation of Hamdard Laboratories 2 drops in each nostril will be given to the patient on bedtime daily for 28 days and Tiryaq Isaba wa Shaqiqa will be made available to the patients in the form of powder Safuf and they will be advised to mix it in 90 ml of plain water and drink it every morning for 28 days 
Comparator Agent  Tiryaq Isaba wa Shaqiqa  Tiryaq Isaba wa Shaqiqa will be made available to the patients in the form of powder Safuf and they will be advised to mix it in 90 ml of plain water and drink it every morning for 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of 18 to 50 years of age
Patients of all sexes
Clinically diagnosed patients of Migraine without aura according to ICHD criteria
Patients who will give consent and are able to do follow up
 
 
ExclusionCriteria 
Details  Patients below 18 and above 50 years of age
Severe Anaemic patients
Patients with known mental and psychiatric disorder
Having systemic disorders
Patients with a history of allergies especially to any component in the study drug
Pregnant and lactating women Head injury Sinusitis Brain tumors
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale  On Day 0,7,14,21,28 
 
Secondary Outcome  
Outcome  TimePoints 
Migraine Specific Quality Of Life Questionnaire  On Day 0 and 28 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   08/09/2025 
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="0"
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  
The term hemicrania refers to migraine, a primary headache disorder documented since ancient Mesopotamian times. Hippocrates first described it, and Galen provided further explanations regarding its location and cause. Migraine presents as recurrent pulsating headaches often with nausea, vomiting, light and sound sensitivity, and sometimes aura. It usually begins on one side of the head and varies in intensity, frequency, and duration. Globally, it is the third most common disease, affecting about 14.7 percent of people, more prevalent in women than men. The International Headache Society identifies two main types: migraine without aura (80–85 percent of cases) and migraine with aura (15–20 percent). While once thought to be purely vascular, current research links it to nerve and neurotransmitter involvement, including serotonin and CGRP. In Unani medicine, migraine is called Shaqiqa, from the Arabic word meaning half part. It is associated with nausea, vomiting, and unilateral head pain. The cause is considered an imbalance in temperament due to morbid matter, sometimes in the scalp muscles or meninges. Tabari noted the lack of morbid matter in scalp arteries prevents pain from spreading to the whole head. Some Unani physicians attribute it to thick fluids or vapors collecting in a weaker area of the head. Galen believed it indicated weakness on one side of the head. Unani classifies Shaqiqa into four types based on humors: Damawi (blood), Safrawi (bile), Balghami (phlegm), and Sawdawi (black bile), further grouped into hot and cold categories. Traditional Unani literature records many safe and effective remedies for Shaqiqa, and the present study aims to assess their efficacy and safety. Qutoor means drops instilled into the nose, ears, or eyes for therapeutic purposes.
For migraine (Shaqiqa), Qutoor with Roghan-e-Banafsha (oil of Viola odorata, sweet violet) is used as part of local therapy. Tiryaq Isaba wa Shaqiqa in the Unani System of Medicine is a classical compound formulation specifically designed for diseases of the nervous system, especially headaches and migraines (Shaqiqa).
 
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