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
|
|
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
|
|
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
|
|
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. |