| CTRI Number |
CTRI/2019/02/017857 [Registered on: 27/02/2019] Trial Registered Prospectively |
| Last Modified On: |
12/05/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Dermatophytosis (Ringworm) with Unani medicine Majoon-e-Ushba and Marham Qooba |
|
Scientific Title of Study
|
Clinical Validation of Unani Pharmacopoeial formulations Majoon-e-
Ushba and Marham Qooba in Qooba (Dermatophytosis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Q/D/MU/MQ/CLNVAL/CCRUM /17-18, version 1 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Asim Ali Khan |
| Designation |
Director General |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
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 |
unanimedicine@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Naheed Parveen |
| Designation |
Assistant Director |
| Affiliation |
Central Council for Research in Unani Medicine (CCRUM) |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri
South West
DELHI
110058
India |
| Phone |
9213511298 |
| Fax |
|
| Email |
ccrum507@rediffmail.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 |
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), Mumbai 2. Regional Research Institute of Unani Medicine (RRIUM), Chennai 3. Regional Research Institute of Unani Medicine (RRIUM), Patna Monetary Support : Central Council for Research in Unani Medicine (CCRUM), New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM |
| 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 Irfan Ahmad |
Regional Research Institute of Unani Medicine (RRIUM) |
Behind Eye Bank, Sir J J Hospital Compound, Byculla
Research OPD Room (Qooba)
Mumbai
MAHARASHTRA |
02223742173
rrium.mumbai@gmail.com |
| Dr K Kabiruddin Ahmed |
Regional Research Institute of Unani Medicine (RRIUM) |
1, West Madha Church, Royapuram
Research OPD Room (Qooba)
Chennai
TAMIL NADU |
9444219145
drk.kabiruddin@rediffmail.com |
| Dr Mohd Manzar Alam |
Regional Research Institute of Unani Medicine (RRIUM) |
Guzri, Patna City
Research OPD Room (Qooba)
Patna
BIHAR |
7488966960
manzar.medicine@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Regional Research Institute of Unani Medicine, Chennai |
Approved |
| Regional Research Institute of Unani Medicine, Mumbai |
Approved |
| Regional Research Institute of Unani Medicine, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B359||Dermatophytosis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-e- Ushba and Marham Qooba |
Majoon-e- Ushba 10 g Twice daily Orally with water for 5 weeks
Marham Qooba Q.S. Twice daily Topically on the affected area after rubbing for few seconds for 5 weeks. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of either sex aged between 18- 65 years
2. Subjects with KOH positive/microscopically confirmed
3. Clinical signs and symptoms suggestive of fungal infection viz. annular / arcuate
polycyclic lesion with clear centre and an active margin with papulo-vesicles & scaling;
erythema, itching, burning. |
|
| ExclusionCriteria |
| Details |
1. Patients of either sex < 18 years and > 65 years
2. Superficial skin disease like Eczema/psoriasis/scabies
3. Superadded infections
4. Lactating and pregnant women
5. Subjects with Tinea capitis (tinea of scalp), Onychomycosis (tinea of nails) and Tinea
barbae (tinea of beard)
6. Subjects who are concomitantly using any anti-fungal product in any form
7. Known cases of allergy to any ingredients of the study drug
8. Subjects with systemic diseases requiring long-term treatment
9. Subjects not willing to undergo the specified washout periods (for topical preparations
not less than 2 weeks & for systemic medicines 4 weeks) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in sign and symptoms of Qooba (Dermatophytosis) |
05 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety assessment |
Investigations will be done at baseline and end of treatment |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
28/02/2019 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is designed as a multicentric open trial in patients with Qooba (Dermatophytosis). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at week 0, 02 and 05. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 5 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.Composition of Majoon-e-Ushba
|
S. No.
|
Unani Name
|
Scientific Name
|
Weight
|
|
1.
|
Ushba
|
Smilax ornate Lem.
|
20 g
|
|
2.
|
Bisfaij Fastaqi
|
Polypodium vulgare Linn.
|
20 g
|
|
3.
|
Aftimun Vilayti
|
Cuscuta eurea Linn.
|
20 g
|
|
4.
|
Barg-e-Gawzaban
|
Onasma bracteatum Wall.
|
20 g
|
|
5.
|
Kabab chini
|
Piper cuceba Linn.
|
20 g
|
|
6.
|
Darchini
|
Cinnamonium zeylanicum
|
20 g
|
|
7.
|
Gule Surkh
|
Rosa damascene
|
30 g
|
|
8.
|
Chobchini
|
Smilax china Linn.
|
30 g
|
|
9.
|
Sandal Safaid
|
Santalum album Linn.
|
30 g
|
|
10.
|
Sandal Surkh
|
Pterocarpus santalinus Linn.
|
30 g
|
|
11.
|
Senna Makki
|
Cassia angustifolia
|
40 g
|
|
12.
|
Post Balela,
|
Terminalia belirica Roxb.
|
10 g
|
|
13.
|
Sumbul-ut-Teeb
|
Valeriana jatamansi DC.
|
10 g
|
|
14.
|
Halela Siyah
|
Terminalia chebula Retz.(Black)
|
7 g
|
|
15.
|
Post Halela Zard
|
Terminalia chebula Retz.(yellow)
|
6 g
|
|
16.
|
Qand Safaid
|
Sucrose
|
750 g
|
|
17.
|
Shahad
|
Honey
|
500 g
|
|