跳至主要内容
临床试验/CTRI/2024/02/062474
CTRI/2024/02/062474尚未招募2 期

Clinical Study of Buthur Labaniyya (Acne vulgaris) and Therapeutic Evaluation of Unani Formulation of Dimad (Paste) in it’s management; An Open-label, block randomized, standard control study.

Central Council for Research in Unani Medicine New Delhi1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年2月15日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
1.Change in inflammatory lesions (Papules and Pustules) and non-inflammatory lesions (Open and Closed Comedones) (GAGS-Global Acne Grading System).

研究概览

简要总结

Buthur Labaniyya (Acne vulgaris) is a self-limiting disorder of teenagers and young adults; although 10-20% of adults may continue to experience some form of the disorder. The Global burden disease (GBD) project estimates the prevalence of acne vulgaris at 9.4%, ranking it as the eighth most prevalent disease worldwide. Acne vulgaris affects both sexes equally but its age of onset is usually earlier in females (16-17 years) than in males (17-19) years. Acne vulgaris is a dermatosis of unknown etiology but androgenic stimulation at puberty is believed to increase the activity of sebaceous glands and sebum production. Sebum flow is impeded because of abnormal keratinization within the pilosebaceous canal, a process that leads to formation of comedones. Bacterial (propiobacterioum acnes) proliferation within the comedones predisposes to rupture of pilosebaceous unit with extravasations into the surrounding dermis, which results in papules, pustules, and cysts. Acne mostly occurs on face and back of neck but can also occur on chest and upper back. In Unani system of medicine, Buthur Labaniyya (Acne vulgaris) is defined as appearance of white papules on face and nose accompanied by discharge of viscous fluids from them. Unani Physicians have explained the cause of Buthur Labaniyya (acne vulgaris) as Madda-i-Sadidiya (suppurative material) which comes to the skin surface due to vapors of the body (bukharat-i-badan) and have also recommended the use of drugs (either orally or locally) having Muhalil (anti- inflammatory), Mujaffif (Desiccative) and Jali (Detergent), Dafi-Taffun (Antiseptic) properties. The allopathic approach for the treatment of Acne vulgaris is either pharmacological (Ilaj bil Dawa) or surgical (Ilaj bil Yad). Pharmacological therapies include; topical application of sulfacetamide, salicylic acid, azelaic acid and retinoid and oral administration of antibiotics (tetracycline, macrolides, clindamycin and dapsone) and anti-androgens (spironolactone, cyproterone), while as surgical procedures includes incision and curettage. Although not life threatening, acne leads to significant morbidity,including depression,anxiety,and psychosocial stress,and is the major cause of psychosocial and psychological impairment for young people triggering anxiety and mood disorders and effecting self esteem. Most of the allopathic drugs are costly, having potential adverse effects and producing only time being relief to the patients. Therefore a clinical trail entitled “Clinical Study of Buthur Labaniyya (acne vulgaris) and Therapeutic Evaluation of Unani Formulation of Dimad (Paste) in it’s management; An Open- label, block randomised, standard control study”is contemplated with the objective to evaluate the therapeutic efficacy of Dimad (Paste) in acne and improve the quality of life. In this regard a Unani formulation as mentioned in classical Unani literature and comprising of Alsi (Linum usitatissimum), Gul-e-Surkh (Rosa damascene Mill), Kalonji’ (Nigella sativa) and Sirka (Vinegar) will be evaluated in the management of acne vulgaris.

The above mentioned ingredients Alsi (Linum usitatissimum),Gul-e-Surkh (Rosa damascene Mill), Kalonji’ (Nigella sativa) and Sirka (Vinegar) have Muhalil  (anti-inflammatory), Dafi-Taffun (Antiseptic), Mukhrij-i-Balgham (Expectorant), Mujaffif (Dessicative), Mufattih (Deobstruent) properties.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
15.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients of age group 15-60 years.
  • Clinically diagnosed patients of Buthur Labaniyya.
  • Patients Irrespective of the gender.
  • Patients with mild to moderate form of acne.
  • Patients who will agree to sign the informed consent form & follow the protocol.

排除标准

  • Patients with severe form of acne.
  • Diagnosed patients of PCOD.
  • Patients having local wound and infection on face.
  • Pregnant and lactating women.
  • Patients with systemic diseases like DM, CKD, Chronic liver diseases,and history of Thyroid diseases or malignancies.
  • Patients on corticosteroid therapy, anti-convulsant therapy or taking OCP.
  • Patients suffering from other concomitant diseases like acne rosacea, acne fulminans, acne necrotica, psoriasis, eczema etc.

结局指标

主要结局

1.Change in inflammatory lesions (Papules and Pustules) and non-inflammatory lesions (Open and Closed Comedones) (GAGS-Global Acne Grading System).

时间窗: 0th day, 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day

2) Change in the inflammatory (Papules and Pustules) lesions based on photographs of lesions.

时间窗: 0th day, 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day

3) Change in the quality of life of subjects based on the Dermatology Life Quality Index (DLQI).

时间窗: 0th day, 7th day, 14th day, 21st day, 28th day, 35th day, 42nd day

次要结局

  • 1) Effect on redness based on Clinical Erythema Assessment (CEA).(2) Effect on eruptions based on Simple Grading System by Indian Authors.)

研究者

发起方
Central Council for Research in Unani Medicine New Delhi
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Dr. Shameem Ahmad Rather

Regional Research Institute of Unani Medicine (RRIUM), Srinagar

研究点 (1)

Loading locations...

相似试验