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CTRI Number  CTRI/2018/03/012584 [Registered on: 15/03/2018] Trial Registered Prospectively
Last Modified On: 25/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   Treatment of Headache with Unani formulation using hydrotherapy  
Scientific Title of Study   Effect of Nutul-i-Har in treatment of Shaqiqa Muzmin (Chronic Migraine) 
Trial Acronym  NHCMT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MOHD UMAR AFZAL AKHTAR AHSAN 
Designation  pg scholar 
Affiliation  National Institute of Unani Medicine 
Address  NIUM, KOTTIGEPALAY, MAGADI MAIN ROAD BANGALURU

Bangalore
KARNATAKA
560091
India 
Phone  7977190855  
Fax    
Email  drmuafzal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abdul Nasir Ansari 
Designation  Reader 
Affiliation  NIUM 
Address  NIUM, KOTTIGEPALAY, MAGADI MAIN ROAD BANGALURU

Bangalore
KARNATAKA
560091
India 
Phone    
Fax    
Email  abdulnasiransari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Abdul Nasir Ansari 
Designation  Reader 
Affiliation  NIUM 
Address  NIUM, KOTTIGEPALAY, MAGADI MAIN ROAD BANGALURU

Bangalore
KARNATAKA
560091
India 
Phone    
Fax    
Email  abdulnasiransari@gmail.com  
 
Source of Monetary or Material Support  
NIUM 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  NIUM, KOTTIGEPALAY, MAGADI MAIN ROAD BANGALURU 
Type of Sponsor  Research institution and hospital 
 
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 
MOHD UMAR AFZAL  National Institute of Unani Medicine  NIUM, KOTTIGEPALAY, MAGADI MAIN ROAD BANGALURU
Bangalore
KARNATAKA 
07977190855

drmuafzal@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC-NIUM  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  CHRONIC MIGRAINE,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  Nutool (Irrigation)  Decoction of following medicines will be used for Nutool (Irrigation). Nutool will be done on alternate day with fresh medicine. 1.Ikleel ul malik (Melilotus officinalis)-12 grams/day 2.Baboona (Anthemis nobilis)-12 grams 3.Hulba (Trigonella foenum)-12 gm 4.Afsanteen (Artemisia absinthium)-12 grams 5.Marzanjosh (Ipomea reniformis)12 grams 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Clinically diagnosed Patients of chronic migraine as per ICHD criteria12
2.Patients aged between 18 –60 years
3.Either gender
4.Willing to fill daily headache diary
5.Patient willing to sign written informed consent
 
 
ExclusionCriteria 
Details  1.Non-migraineous headache: tension-type headache; cluster headache; chronic paroxysmal or non-paroxysmal hemicranias
2.Familial hemiplegic migraine
3.Below 18 and above 60 years
4.Pregnancy and Lactation
5.H/O Neuropsychiatric illness
6.H/O any systemic illness or metabolic disorders
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue scale (VAS)
Migraine disability assessment (MIDAS)
 
0, 15, 30, 45, 60, 90th day
 
 
Secondary Outcome  
Outcome  TimePoints 
MSQL  0,30,60, 90 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   24/03/2018 
Date of Study Completion (India) 29/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Shaqiqa (migraine) is type of Headache which is typically unilateral  but sometimes bilateral  and moderate to severe in intensity. Migraine is the second most prevalent brain disorder after anxiety. It has two major clinical subtypes, migraine without aura (common migraine) which occurs in about 80 to 85% of patient and migraine with aura (classical migraine) which occurs in about 15 to 20% of patients. In US the direct and indirect cost associated with migraine is over $20 billion annually. The Global Burden of Disease Study 2010 (GBD2010) ranked tension type headache (TTH) and migraine as the second & third most common disease worldwide. According to the World Health Organization’s 2012 global burden of disease, the cumulative burden of the disorder caused it to rank in the top 40 conditions causing worldwide disability. A study conducted at Bangalore in 2016 shows out of total cases of headache yesterday, 46.3% were migraine headache. Thus, it is understandable that migraine is one of the leading disabling causes in adults and high burden of disease. Thus effective treatment of migraine is needed with fewer side effects. Despite having effective treatment for acute migraine attacks (such as Triptans) the response rate varies from 44-70%. Some patients do not get relief by 2 hours after taking oral migraine medications, and recurrence of headache within 24 hours of initial dosing is common. In addition these medicines have adverse effects such as NSAIDs cause dyspepsia and gastrointestinal irritation; Ergotamine may cause nausea. Triptans which are considered as important medicine for acute migraine treatment are generally not effective in migraine with aura unless given after the aura is completed and the headache initiated, and recurrence of headache within usual time of course of an attack occurs in most of the patients. The prophylactic agents available have limited efficacy and may cause adverse effects and not compatible for long term use. Unani physicians have successfully treated Shaqiqa since ancient times without any significant side effects on the basis of the principles of Tanqia Mawad-i-Raddiya and Taqwiat-i- Dimagh achieved by using Munzij wa Mus’hil and Nutul, Saʹoot wa Zimad. Keeping this in view, a study is planned to evaluate the efficacy of Unani treatment in management of Migraine using Nutul-i-Har on affected side. The goals of managing migraine are to reduce migraine frequency, severity, disability and improve the quality of life.

 
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