Evaluating efficacy of unani formulation in Acne.

Phase 2/3

Not yet recruiting

Conditions: Acne vulgaris,

Registration Number: CTRI/2023/10/058541

Lead Sponsor: National Research Institute of Unani Medicine for Skin Disorders

Brief Summary: *Buthur Labaniyya*(Acne Vulgaris) is the most common skin disease, affect 9.4% of the global population, making it the eighth most prevalent disease worldwide. According to the GBD study, acne vulgaris affects ~85% of young adultsâ€™ aged 12â€“25 years. Acne causes disfigurement which leads to great psychological, emotional and social impact. Anxiety, depression, bullying, lack of confidence, social withdrawal, feelings of insecurity and inferiority even suicidal ideation. In conventional therapy, there are many drugs are available but none of them are free from side effects. Marham hina, is a potent topical treatment from National Formulary of Unani Medicine for Acne Vulgaris.

This Randomized, Active controlled, Parallel Group, Open Label, Clinical study has planned to evaluate the Efficacy and Safety of Marham Hina in the management of acne vulgaris. Participants fulfilling inclusion and exclusion criteria will be receive either test or control drug as per randomization, in test group participants will be receive Marham Hina ointment local application twice daily at affected sites as per requirement, in control drug participants will be given benzoyl peroxide 2.5% gel topically twice daily at affected sites as per requirement. Laboratory investigation will be done at baseline and last follow up. Duration of the study is 6 weeks. For 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

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Participants of any gender in the age group between 12 to 30 years.
Participants having any of the following symptoms of Buthur Labaniyya as Comedones, Papules,Pustules ,Nodules, Itching , Erythema.
Participants who are willing to participate and comply with the protocol and to sign IEC approved informed consent / assent form.

Exclusion Criteria

Participants aged <12 years and > 30 years.
Participants with other variants of acne like acne fulminans, acne rosacea, acne necrotica.
Participants suffering from other concomitant diseases like vitiligo, dermatophytosis, psoriasis and eczema.
Pregnant or Nursing Women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
25% Reduction in Global Acne Grading System Score from baseline	6 Weeks

Secondary Outcome Measures

Name	Time	Method
1.Reduction in Cooks Acne Grading Scale , Dermatology Life Quality Index , Visual Analogue Scale Score from baseline	2. Improvement in symptoms from baseline

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
Dr Khan Shama Rahimullah
Principal investigator
8999285065
khanshama41@gmail.com