| CTRI Number |
CTRI/2024/11/076962 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of skin rash with Unani medicine Majoon Musaffi-Azam |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial Formulation
Majoon Musaffi-Azam in Busoor (skin eruptions) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BSR/SE/MMA/CLNVAL/CCRUM/2022-23, version 01, 07.06.2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr N Zaheer Ahmed |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 502, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
01128525715 |
| Fax |
|
| Email |
drnzaheer@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ghazala Javed |
| Designation |
Assistant Director (Unani) |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 506, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9811810454 |
| Fax |
|
| Email |
javed.ghazal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pradeep Kumar |
| Designation |
Research Officer (Pathology) S-IV |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
8800263300 |
| Fax |
|
| Email |
drpradeepkumar2001@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Infrastructural support : 1 Regional Research Institute of Unani Medicine (RRIUM), Srinagar 2. Clinical Research Unit (CRU), Bengaluru 3. Clinical Research Unit (CRU), Burhanpur. Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy 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 = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arisha Shahid |
Clinical Research Unit |
Research OPD Room Busoor (skin eruptions),At National Institute of Unani Medicine, Kotigepalya, Magadi Main Road, Bangalore
Bangalore
KARNATAKA |
9972638514
arishashahid0000@gmail.com |
| Dr Yasmin Fatima |
Clinical Research Unit |
Research OPD Room Busoor (skin eruptions), Saeeda Hospital Campus, Ganpati Naka, Burhanpur
West Nimar
MADHYA PRADESH |
8827166845
yas.fatima2014@gmail.com |
| Dr Huma |
Regional Institute of Unani Medicine (RRIUM) |
Research OPD Room Busoor (skin eruptions), Naseem Bagh Campus, University of Kashmir, Srinagar
Srinagar
JAMMU & KASHMIR |
9796550059
humaccrum@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinical Research Unit, Bangalore |
Approved |
| Clinical Research Unit, Burhanpur |
Submittted/Under Review |
| Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R21||Rash and other nonspecific skin eruption, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-Musaffi-e-Azam |
7g (semisolid) to be taken orally twice a day with water after breakfast and after dinner for 4 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex
2. Patients in between age 12 to 60 Age Group
3. Frequently occurrence of Busoor, with or without association of following features.
- Humra (Erythema)
- Waja (Pain)
- Hikka (Itching) |
|
| ExclusionCriteria |
| Details |
1. Patients of Busoor associated with fever.
2. Patients with other inflammatory and suppurated conditions of skin e.g. Abscess, Carbuncle, and Cellulitis.
3. Patients with features of Cellulitis
4. Patients with diabetes mellitus
5. Patients with disease required long term treatment e.g. Metabolic Disorders, specific infectious disease and cancer etc.
6. Pregnancy and lactation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The lesion will be evaluated according to its number, size, and associated symptoms. Grading on the basis of the number of lesions will be recorded. |
At baseline, day 7, 14, 21 and at the end of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination. |
At baseline and after 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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 3 |
|
Date of First Enrollment (India)
|
29/11/2024 |
| 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 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
|
This study is designed as a multi centric open trial in patients with Busoor (skin eruptions). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 04 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Majoon-musaffi-e-Azam:
|
S. No.
|
Ingredients
|
Botanical
Names
|
Quantity
|
|
1
|
Barg-e-Shahtra
|
Fumaria officinalis Linn.
|
200gm.
|
|
2
|
Post halela Zard
|
Terminalia chebula Retz. Yellow
|
160gm.
|
|
3
|
Post halela Kabuli
|
Terminalia chebula Retz. Black
|
120gm.
|
|
4
|
Post balela
|
Terminalia bellirica
(Gaertn.) roxb.
|
400gm.
|
|
5
|
Amala Khusk
|
Emblica officinalis Gaertn
|
400gm.
|
|
6
|
Post halela siyah
|
Terminalia chebula Retz.
|
300gm.
|
|
7
|
Barg-e-Sana
|
Cassia angustifolia Vahl
|
50gm.
|
|
8
|
Gul-e-Surkh
|
Rosa indica
L.
|
120gm.
|
|
9
|
Maweez-e-Munaqqa
|
Vitis vinifera L.
|
1.5Kg.
|
|
10
|
Bisfaij Fistaqi
|
Polypodium vulgare Linn.
|
130gm.
|
|
11
|
Aftimoon
|
Cuscuta reflexa Roxb
|
130gm.
|
|
12
|
Turbud
|
Operculina turpethum (Linn.)
|
130gm.
|
|
13
|
Qand Safaid
|
Sugar
|
08Kg.
|
|