Evaluating the therapeutic effects of a Unani Formulation of Lattukh (smear) in the management of Buthur Labaniyya (Acne vulgaris): A single blind, randomized, standard control study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1) Change from baseline to day 41st in the inflammatory (Papules and pustules) lesions and non-inflammatory (open and closed comedones) lesions (GAGS- Global Acne Grading System).
研究概览
简要总结
Acne vulgaris is a common skin condition characterized by comedones, inflammatory lesions like papules, pustules, nodules and cysts; and scars mainly on face, chest and upper back. The prevalence of Acne vulgaris is believed to be 85% among teenagers and young adults, making it one of the most prevalent skin diseases worldwide. The lesions disappear in the third decade of life in roughly 70% of patients. Both the genders are equally affected;however, men are roughly ten times more likely to develop nodulocystic acne. A lot of mental issues are frequently linked to have a relatively disfiguring skin condition during a time when a person is developing his social identity. Acne vulgaris is a major contributor to psychosocial and psychological impairment in young people, causing anxiety and mood disorders and lowering self-esteem, even though it is not life threatening. The incidence of Acne vulgaris appears to be increasing globally. Acne vulgaris has been recognized and described by various Unani physicians. It has been described as small, white lesions on the nose and cheeks, resembling droplets of condensed milk and as the lesions mature and develop fully, they exude peep (pus). The Madda-i-Ṣadidiya (infected matter) that causes these lesions is brought to the skin surface by the bukarat-i-badan (body vapours) and the condition is treated with drugs having Tajfif (desiccant) and Tahlil (resolving) properties. The formulation of Lattukh (smear) consists of Injir (Ficus carica Linn), Kalonji (Nigella sativa) and Sirka ( Grape vinegar) and all the three drugs possess the above mentioned properties. In contemporary system of medicine, there are many treatment modalities available but all have side effects, and pose an economical burden and some people don’t respond well to them. The management of Acne vulgaris depends on its severity and subtype. Topical medications like benzoyl peroxide, retinoids, and topical antibiotics can be used to combat mild tomoderate forms of Acne vulgaris, however, each of them develops side effects like xerosis, erythema, skin irritation such as itching, burning and stinging sensation. Oral antibiotics like tetracyclines, macrolides and clindamycin can be used with topical medications to alleviate moderate to severe forms of Acne vulgaris but have associated detrimental effects such as nausea, vomiting or diarrhoea, abdominal pain; hypersensitivity reactions (pneumonitis, eosinophilic nephritis, serum sickness), autoimmune disorders (SLE, autoimmune hepatitis, polyarthritis nodosa), dizziness, headache, and photosensitivity associated with tetracyclines. Acne vulgaris in females can be treated with hormonal therapy, such as spironolactone or combination oral contraceptives. Isotretinoin, a systemic retinoid, is the treatment of choice for severe nodulocystic acne. Although it is quite successful, it can have major detrimental effects, such as teratogenicity and psychiatric side effects, and it needs to be closely monitored. The necessity to authenticate the activity of Unani drugs, which are safe, effective, and have limited side effects, emerges in view of aforementioned facts in order to cure the condition and enhance the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 40.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age between 12-40 years.
- •Patients with mild to moderate forms of acne.
- •Irrespective of gender.
- •Patients with itching, erythema, comedones, papules and pustules.
- •Patients who are willing to give consent and are able to follow up.
排除标准
- •Patients below 12 years and above 40 years of age.
- •Patients with severe forms of acne.
- •Diagnosed patients of PCOS.
- •Pregnant and lactating women.
- •Patients on corticosteroid therapy and on OCP’s.
- •Patients suffering from systemic illnesses like Cardiovascular disease, chronic kidney disease and chronic liver disease, thyroid disease or malignancy.
结局指标
主要结局
1) Change from baseline to day 41st in the inflammatory (Papules and pustules) lesions and non-inflammatory (open and closed comedones) lesions (GAGS- Global Acne Grading System).
时间窗: 40 days.
2) Change from baseline to day 41st in Investigator’s Global Assessment of Acne (IGA).
时间窗: 40 days.
3) Change from baseline to day 41st day in the inflammatory (papules and pustules) lesions
时间窗: 40 days.
based on photographs of lesions.
时间窗: 40 days.
4) Change from baseline to day 41st day in the quality of life of subjects based on the Dermatology Life Quality Index (DLQI).
时间窗: 40 days.
次要结局
- 1)Effect on itching based on Visual Analogue Scale (VAS).(2) Effect on redness based on Clinical Erythema Assessment (CEA).)
