| CTRI Number |
CTRI/2025/02/080213 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
The effectiveness of steam inhalation and pistachio oil in treating migraine. |
|
Scientific Title of Study
|
Efficacy of Inkibab and Saut of Roghan-i-Pista in Shaqiqa (Migraine) A Randomized placebo controlled, Assessor Blinded 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 |
Nawaz Ahmed Y |
| Designation |
PG Scholer |
| Affiliation |
National Institute Of Unani Medicine, Bangalore |
| Address |
Department Of Ilaj Bit Tadbeer, National Institute Of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
7676416032 |
| Fax |
|
| Email |
nawazahmed1023na@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Unani Medicine, Bangalore |
| Address |
Department Of Ilaj Bit Tadbeer, National Institute Of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9035417278 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Azeez |
| Designation |
Associate Professor |
| Affiliation |
National Institute Of Unani Medicine, Bangalore |
| Address |
Department Of Ilaj Bit Tadbeer, National Institute Of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
9035417278 |
| Fax |
|
| Email |
aafaris@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine, Kottigepalya, Magadi main road, Bangalore,560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine, Bangalore |
| Address |
National Institute of Unani Medicine, Magadi Main Road,
Kottigepalya Bangalore - 560091 Karnataka, India
|
| 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 |
| Nawaz Ahmed Y |
National Institute Of Unani Medicine |
Department Of Ilaj Bit Tadbeer, OPD 28, National Institute Of Unani Medicine, Magadi Main Road, Kottigepalya, Bangalore, 560091
Bangalore
KARNATAKA |
7676416032
nawazahmed1023na@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethical Committee ((IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inkibab (steam inhalation) followed by Saut (nasal instillation) of Roghan-i-Pista (pistachio oil).
|
In the Test group 2 drops of Roghan-i-Pista in each nostril, twice daily followed by steam inhalation |
| Comparator Agent |
Will receive only nasal instillation of normal saline
|
Control group will receive 2 drops of normal saline in each nostril, twice daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient Diagnosed cases of Migraine (as per the International Classification of Headache Disorders (ICHD-3)
2.Patient having Pain intensity on the VAS scale between 3-7
3.Patients between the age of 18–50 years
4.Patients of any gender
5.Patients who will give consent and can do follow-up
|
|
| ExclusionCriteria |
| Details |
1.Patient use of any migraine prophylactic agents (b-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents, cycle-modulating hormonal drugs, or vessel dilatation agents) within 1 month prior to screen
2.Patient having history or evidence of psychiatric disorder patients
3.Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Pain intensity –Migraine Disability Assessment (MIDAS)
•Headache frequency and duration from the headache diary |
Base Line,15th,30th,45th,60th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)22 |
Base Line,15th,30th,45th,60th |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
03/03/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Purpose: Efficacy of Inkibāb and Sa‘ūṭ of Roghan-i-Pista in Shaqīqa (Migraine) Design :A Randomized Placebo-Controlled Assessor blinded Clinical Trail
Intervention: Test group: will receive Inkibāb (steam inhalation) followed by Sa‘ūṭ (nasal instillation) of Roghan-i-Pista (pistachio oil). Control group: will receive only nasal instillation
Outcome Measures: Primary Outcome: Pain intensity –Migraine Disability Assessment (MIDAS) Headache frequency and duration from the headache diary Secondary Outcome: Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)
|