| CTRI Number |
CTRI/2020/06/025718 [Registered on: 09/06/2020] Trial Registered Prospectively |
| Last Modified On: |
27/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Unani drug (shoniz with sirka) on Buthur labanniya (Acne vulgaris) |
|
Scientific Title of Study
|
“Clinical Study of Buthur Labaniyya (Acne Vulgaris) With Therapeutic Evaluation of Topical Unani Drug, Shoniz (Nigella sativa) and Sirka (vinegar) in its Management.†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gousia Mehraj |
| Designation |
PG scholar |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalajat,RRIUM,Naseem Bagh Campus
University of Kashmir,Hazratbal
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9596123062 |
| Fax |
|
| Email |
gousianizami00@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor Naquibul Islam |
| Designation |
Professor |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalajat,RRIUM,Naseem Bagh Campus
University of Kashmir,Hazratbal
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
9469154930 |
| Fax |
|
| Email |
naquibislam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shameem Ahmed Rather |
| Designation |
Reader |
| Affiliation |
Regional Research Institute of Unani Medicine |
| Address |
Department of Moalajat,RRIUM,Naseem Bagh Campus
University of Kashmir,Hazratbal
Srinagar
JAMMU & KASHMIR
190006
India |
| Phone |
7889584083 |
| Fax |
|
| Email |
shameem.rather.sr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine,New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani MedicineNew Delhi |
| Address |
Regional Research Institute of Unable Medicine (RRIUM),University of Kashmir,Srinagar,CCRUM,New Delhi |
| Type of Sponsor |
Research institution |
|
|
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 |
| Dr Gousia Mehraj |
Regional Research Institute of Unani Medicine |
Moalajat OPD-2, Ground floor, RRIUM,Naseem Bagh Campus,University of Kashmir,Hazratbal
Srinagar
JAMMU & KASHMIR |
9596123062
gousianizami00@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,RRIUM,Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benzoyl peroxide cream 5% |
Mode of application: Topical
Dose and duration: To be applied locally twice a day on affected areas upto 8 weeks or lesser as per response to treatment |
| Intervention |
Paste of Shoniz and Sirka/vinegar (Topical application) |
Ingredients: Shoniz and Sirka
Method of preparation: Paste of Shoniz and Sirka will be prepared as per standard procedure.
Dosage and duration: To be applied locally twice a day on affected areas upto 8 weeks or lesser as per response to treatment |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically stable patients of Buthur labanniya
2.Patients having comedones,papules,pustules,itching and erythema
3.Patients willing to give consent
4.Patients irrespective of gender
5.Patients in the age group of 10 to 40 years |
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 10 and above the age of 40
2.Pregnant females
3.Lactating mothers
4.Mentally retarded persons
5.Patients with severe acne
6.Patients on corticosteroid therapy,anticonvulsant therapy or taking oral contraceptives
7.Patients suffering from other concomitant diseases like acne rosacea,acne fulminans,acne necrotica,psoriasis or eczema etc
8.Patients diagnosed of PCOS
9.Patients with diabetes mellitus,chronic kidney disease and chronic liver disease
10.Patients with thyroid disease
11.History of allergy to Benzoyl Peroxide
13.Patients who fail to give consent
14.Patients who have used any anti acne treatment in last 30 days
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Relief in signs and symptoms of acne vulgaris (Buthur labanniya) |
2 to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haematological and biochemical assessment for safety |
2 to 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/07/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Buthur labanniya (Acne vulgaris) is a chronic inflammatory disease of pilosebaceous unit presenting with seborrhoea, open and closed comedones, papules, pustules and nodulocystic lesions in severe cases. It affects primarily the face, neck, upper trunk and upper arms. It has been estimated that 70% of general population have some clinically evident acne at some stage during adolescence. As per classical Unani literature, Buthur labanniya are tiny white eruptions on nose and cheeks which resemble with condensed milk droplets. These are caused by suppurative matter which comes to the surface of skin due to bukharat (vapours) of the body. |