跳至主要内容
临床试验/CTRI/2025/03/082481
CTRI/2025/03/082481尚未招募2/3 期

A RANDOMIZED, PARALLEL GROUP, OPEN LABEL, ACTIVE CONTROLLED CLINICAL STUDY TO COMPARE THE SAFETY AND EFFICACY OF A TOPICAL UNANI FORMULATION WITH ADAPALENE (0.1 percent) IN THE MANAGEMENT OF BUTHUR LABANIYYA (ACNE VULGARIS)

National Research Institute of Unani Medicine for Skin Disorders1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年1月6日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Change in GAGS.

研究概览

简要总结

Overall prevalence of Acne worldwide consists of 20.5%.The Prevalence was highest among the age group 16 to 24, reaching 28.4%. Drugs used in conventional medicines are effective, but these drugs are associated with multiple side effects. Keeping all these facts in consideration, Keeoing all these facts in considerations, A topical Unani Formulation given byHakeem Mohammad Azam Khan (1814-1902), for Buthur Labaniyyais used for this clinical trial. This Randomized, Active controlled, Parallel Group, Open Label, Clinical study has planned to evaluate the Efficacy and Safety of a Topical Unani Formulation 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 Topical Unani Formulation as ointment for local application once daily at affected sites as per requirement, in control drug participants will be given Adapalene 0.1% gel topically once daily at affected sites as per requirement.  Laboratory investigation will be done at baseline and last follow up. Duration of the study is 4 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.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, fixed
盲法
Open Label

入排标准

年龄范围
15.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • 1.Clinically diagnosed cases of acne vulgaris.
  • 2.Individuals exhibiting any of the subsequent signs and symptoms of Buthur Labaniyya (Comedones, Papules, Pustules, Nodules, Itching, Erythema).
  • GAGS score less than
  • Clinically stable patients.
  • 3.Participants who are competent to follow up and who will provide assent.

排除标准

  • 1.Individuals who are under 15 or older than
  • 2.Patients with GAGS score more than
  • 3.Individuals who suffer from other types of acne, such as eczema, rosacea, acne necrotica, or acne fulminans.
  • 4.Patients undergoing oral contraceptive or androgen medication, or receiving corticosteroid or anticonvulsant therapy .
  • 5.Pregnant or Lactating Women.Significant Pulmonary/ Cardiovascular/ Hepato-Renal dysfunction and other disorders requiring long-term treatment.Known cases of immunocompromised states (HIV/ AIDS etc.) Malignancies.
  • 6.Patient who have used isotretinoin in last six months.

结局指标

主要结局

Change in GAGS.

时间窗: 0,2 and 4 weeks

次要结局

  • 1.Change in PGA, DLQI Score from baseline(2.Improvement in symptoms from baseline)

研究者

发起方
National Research Institute of Unani Medicine for Skin Disorders
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验