| CTRI Number |
CTRI/2025/01/079475 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Physiotherapy (Not Including YOGA)
Other (Specify) [Saut] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of Unani Polyherbal Formulation in the Management of Chronic Tension Type Headache |
|
Scientific Title of Study
|
Efficacy of Munzij wa Mushil-i-safra and Saut with Roghan-i-kaddu in Usabah (Chronic Tension Type Headache)-A Randomized Controlled 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 |
Tooba Tabassum |
| Designation |
PG Scholar Department of Ilaj bit tadabeer |
| Affiliation |
National Institute Of Unani Medicine Bangalore |
| Address |
Department of Ilaj bit Tadabeer, National Institute OF Unani Medicine,
Kottigepalya, Magadi Main Road, Bangalore
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
7895660852 |
| Fax |
|
| Email |
toobatabassum111@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadabeer, National Institute OF Unani Medicine,
Kottigepalya, Magadi Main Road, Bangalore
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abdul Nasir Ansari |
| Designation |
Head of Department |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilaj bit Tadabeer, National Institute OF Unani Medicine,
Kottigepalya, Magadi Main Road, Bangalore
Bangalore
KARNATAKA
560091
India
Bangalore
KARNATAKA
560091
India |
| Phone |
9379165162 |
| Fax |
|
| Email |
abdulnasiransari@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Kottigepalya, Magadi main road, Bangalore, 560091,
Karnataka |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepalya, Magadi Main
Road, 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 |
| Tooba Tabassum |
National Institute Unani Medicine |
Department of Ilaj bit
Tadbeer , OPD 28,
National Institute of
Unani Medicine,
Kottigepalya, Magadi
Main Road, Bangalore,
Karnataka, 560091
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
7895660852
toobatabassum111@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication Of Decision Of the Institutional Ethics Committee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G442||Tension-type headache, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Munzij wa Mushil-i-safra and Sa’ut with Roghan-i-Kaddu |
Patients of Test Group will be given Munzij-i-Safra for initial 10 days and
Mushil-i-Safra will be added with the former on 5th day and 10th day for Tanqia. The
ingredients of Munzij-i-safra will be soaked in 500 ml of water overnight and decoction
prepared in the morning on low flame till volume reduces to half. After filtration, the decoction
will be given to the patients to drink once in the morning before breakfast daily for 10
consecutive days. On 5th day and 10th day the ingredients of Mushil-i-safra will be added in
the ingredients of Munzij-i-safra, soaked in 750 ml of water overnight; decoction will be
prepared and given to drink in the morning before breakfast for purgation of morbid material.
APPLICATION OF ROGHAN-I-KADDU: Patient will be instilled 2-3 drop of roghan-i
kaddu in each nostril, in the morning at 8 am and evening at 8 pm daily from 11th day of
study to 28th day. |
| Comparator Agent |
Transcutaneous Electrical Nerve Stimulation (TENS) |
Control Group will receive TENS. A pulse rate of 4 Hz and a
pulse width of 200 milliseconds will be used. Electrodes will be placed bilaterally either on the
head at the site of pain or on the occiput. The participants having pain on the forehead will be given TENS over the temporal area of the forehead, whereas, those having it in the occipital
area will be given TENS over the occiput. Each participant in control group will receive one 15-minute session of TENS thrice weekly for 28 days .
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients from 18 to 65 years of age
2. Patients of all gender
3. Patients conforming to ICHD3 diagnostic criteria of CTTH
4. Intensity of headache score on VAS equal or more than 3
5. Agree to participate in this study and provide written informed consent |
|
| ExclusionCriteria |
| Details |
1.Headache caused by other medical disorders (e.g. Known case of subarachnoid hemorrhage,
cerebral hemorrhage, cerebral embolism, cerebral thrombosis, head injury, hypertension,
migraine, headache due to ophthalmic cause)
2. Patients having any serious co-morbidity involving liver, kidney, cardiovascular,
endocrinal and metabolic disorders etc.
3. Pregnant or lactating women
4. Known case of nasal block (polyps, DNS, Turbinate hypertrophy)
5. External injury to nose
6. Patients with pace maker and metallic implant
7. Known case of epilepsy
8. Patients not willing to follow the protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analogue Scale for intensity of headache (VAS) |
0-14-28 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Headache Impact Test (HIT) |
0-14-28 day |
|
|
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)
|
25/02/2025 |
| 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 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
|
Purpose-Efficacy of Munzij wa Mushil-i-safra and Sa’ut with Roghan-i-
Kaddu in Usabah (Chronic Tension Type Headache) - A
Randomized Controlled Clinical Trial
Study design: Open Labelled, Randomized Controlled Clinical Trial
Intervention- In Test group Munzij wa Mushil-i-Safra and Sa’ut with Roghan kaddu will be given Munzij-i-Safra: from 1st day to 10th day
Mushil-i-Safra: on 5th and 10th day.
Sa’ut with Roghan kaddu: from 11th day to 28th days. The patients in control group will recieve Transcutaneous Electrical Nerve Stimulation (TENS) TENS- Thrice weekly for 28 days.
Main outcome measures- Primary outcome: Visual Analogue Scale for intensity of headache (VAS) Secondary outcome: Headache Impact Test (HIT) |