A Randomized, Clinical Study to evaluate the Efficacy and Safety of Polyherbal Unani Formulation in Acne Vulgaris.

Phase 2/3

Not yet recruiting

• Conditions: Acne vulgaris,

• Registration Number: CTRI/2023/03/050164
• Lead Sponsor: National Research Institute of Unani Medicine for Skin Disorders

Brief Summary

ButhÅ«r Labaniyya  (Acne Vulgaris) is a disease of pilosebaceous unit, where lesions develop in the upper-portion of follicular canal, manifests as comedons, papules, pustules and heals with scar. It usually affects 80-90% of individuals at the time of puberty. Both the sex is equally affected. The term ButhÅ«r Labaniyya refers to a whitish discharge resembling milk from eruption. The drugs used in conventional medicine are effective, but shows after-effects after prolonged use. Hence, the safe and effective treatment for acne is required. In Unani Medicine, the drugs have JÄli, Muḥallil, Muá¹£affÄ«-i-Dam properties, but data regarding their efficacy and safety is unavailable. Hence, this clinical trial has been planned to evaluate the efficacy and safety of a polyherbal unani formulation in comparison to benzoyl peroxide 5% gel in the management of acne vulgaris. The participants fulfilling inclusion criteria will be randomly allocated to either of the groups. In test group, the patient will be given unani formulation for local application once daily at bedtime and in control group, the patients will be given benzoyl peroxide 5% gel to be applied locally once daily at bedtime.  Baseline and last follow-up laboratory investigations will be done. Duration of study is 6 weeks

Statistical Analysis: Student t test will be used to find the statistically significant difference in the parameters within the group/ inter the group. all the result analysis will be done using MS excel 2019.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-02-28
• Study Start: 2023-05-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Clinically stable patients 2.
• Patient having chronicity 4 months to 1 year 3.
• Patients having the following symptoms of Buthur Labaniyya: Comedones Papules Pustules Nodules Itching Erythema.

Exclusion Criteria

• Patients aged <15 years or >35 years 2.
• Pregnant or Lactating Women 3.
• Patients on corticosteroid or anticonvulsant therapy or taking oral contraceptives 4.
• Patients suffering from other concomitant diseases, like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema, etc.
• Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction 6.
• Patient not willing to attend treatment schedules regularly.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2. Reduction in Cooks Acne Grading Scale	42 days
1. Reduction in Global Acne Grading System	42 days
4. Improvement in Visual Analogue Scale.	42 days
3. Reduction in Dermatology Life Quality Index	42 days
Outcome measure will be assessed using following parameters:	42 days

Secondary Outcome Measures

Name	Time	Method
Systemic Safety Assessment	42 days

Trial Locations

Locations (1)

National Research Institute of Unani Medicine for Skin Disorders; 🇮🇳 Hyderabad, TELANGANA, India

National Research Institute of Unani Medicine for Skin Disorders

🇮🇳Hyderabad, TELANGANA, India

Tahoora Tamkanat

Principal investigator

8660453834

tamkanattahoora@gmail.com