A Randomized Contrlled Two arm Clinical Trial to Evaluate the Eficacy of a Compound Unani Formula in case of Dandruff
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Excoriation pruritus grading. (EPG)
研究概览
简要总结
· Dandruff also called pityriasis capitis or seborrheic dermatitis is a chronic scalp condition affecting over half the global population Recognized since ancient times it is referred to in Unani medicine as Hazaz or Bafa meaning scalp flakes and dryness It typically begins around or after puberty and is more common in males likely due to androgen involvement Dandruff can impact self esteem and social interactions due to its persistent and visible nature Its cause is multifactorial with the yeast Malassezia playing a key role by breaking down sebum and releasing fatty acids which irritate the scalp and lead to excessive flaking Conventional treatments may cause side effects like itching dryness and dermatitis limiting their use Unani literature offers alternative remedies One such formula was made into a shampoo and tested on albino rats showing no allergic reaction A clinical trial on humans is now planned to assess its safety and effectiveness
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Both sexes Age 13 to 50 years Patients Excoriation Pruritus Grading EPG Adherent Scalp Flaking Score ASFS with any signs and symptoms of hazaz or Bafa Dandruff.
排除标准
- •Patients diagnosed with other scalp diseases Patients who had received any systemic or topical antimycotic therapy within a month of the start of the study Patients undergoing chemotherapy or radiotherapy Immunocompromised patients.
结局指标
主要结局
Excoriation pruritus grading. (EPG)
时间窗: Within 45 days
Adherent Scalp Flaking Score (ASFS)
时间窗: Within 45 days
trying to bring the score below 7
时间窗: Within 45 days
次要结局
未报告次要终点
