Study of the treatment of Acne by Unani ointment

Phase 2

Completed

Conditions: Acne vulgaris, Busur Labaniyya (Acne Vulgaris),

Registration Number: CTRI/2017/12/010974

Lead Sponsor: Central Research Institute of Unani Medicine

Brief Summary: *BusurLabaniyya* (Acne vulgaris) is a folliculardisorder affecting susceptible pilosebaceous follicles, primarily of the face,neck, and upper trunk and characterized by both non-inflammatory andinflammatory lesions. It is one of the most common dermatoses affecting the teenagepopulation. Boys have a peak incidence between age of 16 and 19 years and girlsbetween age of 14 and 16 years. Both sexes are equally affected.

As per Unani classics, *Acne* Vulgaris is termed as*BusurLabaniyya*, *Muhasa* or *Keel*. *BusurLabaniyya*, which means eruptions of milk due to whitish dischargeresembling milk.

*IbnSina* (Avicenna) says in his famous book, *Al-Qanun fiâ€™l Tibb* (Canonof Medicine) that*Muhasa* are small white eruptions on the noseand cheeks which resemble condensed drop of milk.

The drugs used forthe treatment of *Busur Labaniyya* (Acne Vulgaris) inconventional medicine are effective, but pronged use of these drugs may produceside effects like burning, dry skin, erythema, peeling, etc., and recurrence rateis also high.

In Unani Medicine*, Busur Labaniyya* (Acne Vulgaris) is a wellrecognized disease entity and has been treated successfully since antiquitywith various single and compound drugs having *Jali* (Detergent), *Muhalil* (Resolvent)and *Mujaffif* (Desiccative) properties, but data regardingtheir efficacy and safety are not available.

Keeping this in view, it has been planned to conduct a clinicaltrial entitled "A Clinical Study to Evaluate the Efficacy and Safetyof *Tila-i Muhasa* in the Management of *Busur Labaniyya* (AcneVulgaris)".

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 60

Inclusion Criteria

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.
Pustules 4.

Exclusion Criteria

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.
Significant Pulmonary/Cardiovascular/Hepato-renal dysfunction 7.
Patient not willing to attend treatment schedule regularly.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
3. Photographic Standards for Acne Grading (PSAG)	at baseline 2wk 4wk and 6wk
2. Photographic Standards for Acne Grading (PSAG)	at baseline 2wk 4wk and 6wk
The response to treatment will be assessed using the following parameters:	at baseline 2wk 4wk and 6wk
1. Global Acne Grading System (GAGS)	at baseline 2wk 4wk and 6wk

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): Central Research Institute of Unani Medicine
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Central Research Institute of Unani Medicine
🇮🇳Hyderabad, ANDHRA PRADESH, India
Mohd Azahar
Principal investigator
8604039147
mdazharalig09@gmail.com