A Randomized, Parallel Group, Open Label, Standard Controlled Clinical Study to Evaluate Efficacy and Safety of Unani Formulations (Oral and Topical) in Management of Bahaq (Pityriasis Versicolor)
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
- Assessment of Response to Therapy: Clinical assessment will be done at 0,2, 4, 6weeks and the response to treatment will be assessed using the following parameters:
研究概览
简要总结
Pityriasis versicolor (Tinea versicolor or PV) is a superficial fungal infection, characterized by changes in skin pigment due to colonization of stratum corneum by a dimorphic lipophilic fungus of the normal flora of the skin, known as Malassezia furfur . It mostly occurs in young adult, less common when sebum production is reduced or absent; tapper off during 5th and 6th decades of life . In 90% adult Malassezia is commonly found in seborrheic areas and become pathogenic in warm and Humid environment . Its incidence in temperate zone is 2% and in tropical zones 40% . Despite the effective therapeutic regimes available in conventional system of medicine it often possesses a therapeutic challenge . Morbidity results primarily from the discoloration. The adverse cosmetic effect of lesion may lead to significant emotional distress, particularly in adolescents . Despite adequate therapy it frequently recurs and residual pigmentary changes may take several weeks to resolve . Topical drug provides immediate reductions in infectivity but have some disadvantages such as the time needed for therapy, difficult application of the drug over large area of disease, for these reason patient adhesions is inadequate which increase the rate of recurrence. It has impact on patient quality of life. Drugs taken orally affect both disease and normal tissues, thus increasing the chance of side effect and hypersensitivity. Hepatotoxicity is associated with some oral antifungal medications . In patients taking terbinafine concurrently with ketoconazole tablets causes serious ventricular dysrhythmias (in rare cases leading to fatality) have been recorded . For overcoming adverse consequences need arises to seek the solution through herbs . In the Unani system of medicine many herbomineral drugs are used empirically for treatment of Bahaq since antiquity but scientific documentation is not available. It has been planned to conduct a study entitled A Randomized parallel group open label standard controlled clinical study to Evaluate Efficacy and Safety of Unani formulations (Oral and Topical) in management of Bahaq (Pityriasis Versicolor) to generate evidence on scientific tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 19.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Participants of any sex aged 19-60 years Participant having any of the sign and symptoms of Bahaq Hypopigmented macule Hyperpigmented macule Erythema Pruritus on the lesion Scaling / Desquamation and Presence of Malassezia furfurin the scrapings of the lesion.
排除标准
- •Participant with serious co-morbid medical condition and other fungal infection Participant who had received any systemic or topical antimycotic therapy within month of start of study Pregnant or Lactating Women Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies Participant not willing to attend treatment schedule regularly.
结局指标
主要结局
Assessment of Response to Therapy: Clinical assessment will be done at 0,2, 4, 6weeks and the response to treatment will be assessed using the following parameters:
时间窗: outcomes will be assessed at baseline,2 weeks, 4 weeks and at 6 weeks
1.Total sign and symptoms score (TSSS)
时间窗: outcomes will be assessed at baseline,2 weeks, 4 weeks and at 6 weeks
2.Investigator Global assessment
时间窗: outcomes will be assessed at baseline,2 weeks, 4 weeks and at 6 weeks
3.KOH examination:
时间窗: outcomes will be assessed at baseline,2 weeks, 4 weeks and at 6 weeks
4. Fungus Culture: if possible in 5 participants’
时间窗: outcomes will be assessed at baseline,2 weeks, 4 weeks and at 6 weeks
次要结局
- Lab investigation(0 and 6 weeks)
