| 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
|
|
|
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
|
|
|
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). |