| CTRI Number |
CTRI/2024/09/073851 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of migraine through Unani regimens |
|
Scientific Title of Study
|
Development of a Unani treatment protocol comprising oral medication Itrifal Mushil and regimental procedures Natul Irrigation and Dalk Massage by Roghan Banafsha in Shaqiqa Migraine without aura NUMC A 2: An open label, single-arm clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Athar Parvez Ansari |
| Designation |
Research Officer (Unani) |
| Affiliation |
Regional Research Institute of Unani Medicine, Chennai , CCRUM, Ministry of Ayush, Govt. of India |
| Address |
Clinical Research Department, OPD No. 5,
No. 1 West Madha Church Road, Royapuram, Chennai
Chennai
TAMIL NADU
600013
India |
| Phone |
9952961233 |
| Fax |
|
| Email |
aatharparvez@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Athar Parvez Ansari |
| Designation |
Research Officer (Unani) |
| Affiliation |
Regional Research Institute of Unani Medicine, Chennai, CCRUM, Ministry of Ayush, Govt. of India |
| Address |
Clinical Research Department,
OPD No. 5,
No. 1 West Madha Church Road, Royapuram, Chennai
Chennai
TAMIL NADU
600013
India |
| Phone |
9952961233 |
| Fax |
|
| Email |
aatharparvez@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Athar Parvez Ansari |
| Designation |
Research Officer (Unani) |
| Affiliation |
Regional Research Institute of Unani Medicine, Chennai, CCRUM, Ministry of Ayush, Govt. of India |
| Address |
Clinical Research Department,
OPD No. 5,
No. 1 West Madha Church Road, Royapuram, Chennai
Chennai
TAMIL NADU
600013
India |
| Phone |
9952961233 |
| Fax |
|
| Email |
aatharparvez@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine (CCRUM), Ministry of Ayush, Govt. of India |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homeopathy
Anusandhan Bhawan, 61-65 Institutional area, Opp. D block,
Janakpuri, New Delhi 110058 |
| Type of Sponsor |
Research institution |
|
|
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 Athar Parvez Ansari |
Regional Research Institute of Unani Medicine |
Clinical Research Department,
OPD No. 5
No. 1, West Madha Church Road, Royapuram, Chennai
Chennai
TAMIL NADU |
9952961233
aatharparvez@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC RRIUM Chennai |
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 |
1. Natul (Irrigation) therapy
2. Dalk (Massage) therapy
3. Oral medication |
1. Natul will be given with herbal decoction which ingredients are
Sosan (Iris germanica),
Baboona (Matricaria chamomilla
L.), Ikleelul Malik (Trigonella
uncata), Tezpat
(Cinnamomum tamala),
Banafsha (Viola odorata),
Qaranfal (Syzygium aromaticum),
Gul Neelofar Hindi (Nympha alba), Jau (Hordeum
vulgare L.). 7 gm each.
Procedure of Natul: All the ingredients will be boiled in one liter of water for 15 minutes at the boiling point of the water. It will be filtered and left for few a minute to cool. After that, the decoction will be kept in the natūl equipment for irrigation over the forehead and resting part of the scalp from the distance approximately 65 cm for 20 minutes daily for14 days in admitted patients. The eyes will be closed using cotton bandage.
Dose: q. s.
2. Dalk Massage) with Roghan Banafsha
Dose: q. s.
Route of administration: Local application
Frequency: Once a day at bed time
Duration: 28 days
3. Oral medication: Itrifal Mushil
Dose: 10 g
Frequency: Twice a day
Route of administration: Oral
Duration: 28 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A. At least five attacks fulfil criteria B–D.
B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated).
C. Headache has at least two of the following four characteristics:
1. Unilateral location
2. Pulsating quality
3. Moderate or severe pain intensity
4. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs).
D. During headache at least one of the following:
1. Nausea and/or vomiting.
2. Photophobia and/ or phonophobia.
E. Not better accounted for by another ICHD3 diagnosis.
|
|
| ExclusionCriteria |
| Details |
1. Marked depression, anxiety, psychosis, and epilepsy.
2. Mild cases of migraine
3. Pregnancy and lactation.
4. Major medical illness under treatment.
5. Patients with diseases requiring long term treatment.
6. Use of any other alternative medication during the study period.
7. History of alcohol and drug abuse.
8. Diabetes mellitus since the test drug, i.e., Itrīfal Mushil, contains sugar.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Headache frequency and intensity |
0, 7, 14, 28 Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Migraine Disability Assessment Score (MIDAS) |
0, 7, 14, 28 Day |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
20/09/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is an open label clinical trail, which will be carried out on 78 patients of migraine without aura. A combination of Unani regimens including Natul (Irrigation) therapy with herbal decoction will be given for 14 days and massage with Roghan Banafsha and Itrifal Mushil by oral route will be given for 28 days to explore the efficacy and safety of Unani regimens in patients of migraine of without aura. The clinical follow-up will be carried out at 0, 7th, 14th and 28th day. The laboratory investigations such as Hb, TLC, DLC, ESR, routine urine examination, LFT and KFT will be done at 0, 7th day and 28th day. Random blood sugar level will be checked at base line. The efficacy of the Unani regimens in patients of migraine without aura will be assessed based on clinical outcomes. The safety of the Unani regimens will be assessed based on clinical and laboratory findings. |