| CTRI Number |
CTRI/2017/12/010974 [Registered on: 26/12/2017] Trial Registered Prospectively |
| Last Modified On: |
01/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of the treatment of Acne by Unani ointment |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of Tila-i Muhasa in the Management of Busur Labaniyya (Acne Vulgaris) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Azahar |
| Designation |
PG Scholar |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
8604039147 |
| Fax |
|
| Email |
mdazharalig09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor and HoD Moalajat |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Nawab |
| Designation |
Reader |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
8100992044 |
| Fax |
|
| Email |
ccrumnawab@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 |
|
|
Primary Sponsor
|
| Name |
Central Research Institute of Unani Medicine |
| Address |
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 |
| 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 |
| Mohd Azahar |
Central Research Institute of Unani Medicine |
GOPD No. 1 New OPD block, CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038
Hyderabad
ANDHRA PRADESH |
8604039147
mdazharalig09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CRIUM Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, Busur Labaniyya (Acne Vulgaris), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group (A) Unani Drugs: Tila-i Muhasa (Local) |
Patients will be advised to apply Tila-i Muhasa (in the form of paste) locally. 5-10 gm according to affected area, once daily for 42 days.
|
| Comparator Agent |
Group (B) Benzoyl Peroxide 5% Cream |
Patients will be advised to apply Benzoyl Peroxide 5% Cream locally according to affected area once daily for 42 days. |
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
i)Patients of any sex in the age group between 14 and 40 years
ii) Clinically stable patients
iii) Patients having the following symptoms of Busur Labaniyya:
1. Comedones
2. Papules
3. Pustules
4. Nodules
5. Itching
6. Erythema
|
|
| ExclusionCriteria |
| Details |
1. Patients aged <14 years or >40 years
2. Pregnant or Lactating Women
3. Mentally retarded person
4. Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives
5. Patients suffering from other concomitant diseases like acne rosacea, acne fulminance, acne necrotica, psoriasis, eczema, etc.
6. Significant Pulmonary/Cardiovascular/Hepato-renal dysfunction
7. Patient not willing to attend treatment schedule regularly
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The response to treatment will be assessed using the following parameters:
1. Global Acne Grading System (GAGS)
2. Photographic Standards for Acne Grading (PSAG)
3. Photographic Standards for Acne Grading (PSAG) |
at baseline 2wk 4wk and 6wk |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the improvement in quality of life in patients with Acne Vulgaris assessed by PGA on VAS and IGA |
at baseline 2wk 4wk and 6wk |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| Date of Study Completion (India) |
06/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Busur
Labaniyya (Acne vulgaris) is a follicular
disorder affecting susceptible pilosebaceous follicles, primarily of the face,
neck, and upper trunk and characterized by both non-inflammatory and
inflammatory lesions. It is one of the most common dermatoses affecting the teenage
population. Boys have a peak incidence between age of 16 and 19 years and girls
between age of 14 and 16 years. Both sexes are equally affected.
As per Unani classics, Acne Vulgaris is termed as Busur
Labaniyya, Muhasa or Keel. Busur
Labaniyya, which means eruptions of milk due to whitish discharge
resembling milk.
Ibn
Sina (Avicenna) says in his famous book, Al-Qanun fi’l Tibb (Canon
of Medicine) that Muhasa are small white eruptions on the nose
and cheeks which resemble condensed drop of milk.
The drugs used for
the treatment of Busur Labaniyya (Acne Vulgaris) in
conventional medicine are effective, but pronged use of these drugs may produce
side effects like burning, dry skin, erythema, peeling, etc., and recurrence rate
is also high.
In Unani Medicine, Busur Labaniyya (Acne Vulgaris) is a well
recognized disease entity and has been treated successfully since antiquity
with various single and compound drugs having Jali (Detergent), Muhalil (Resolvent)
and Mujaffif (Desiccative) properties, but data regarding
their efficacy and safety are not available.
Keeping this in view, it has been planned to conduct a clinical
trial entitled "A Clinical Study to Evaluate the Efficacy and Safety
of Tila-i Muhasa in the Management of Busur Labaniyya (Acne
Vulgaris)".
|