Randomised clinical trial to compare the efficacy of Lodhradi lepa and Manjishthadi taila Marsha nasya with Lodhradi lepa in Mukhadushika in perspective of acne vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Changes in clinical features like pain, itching, burning ,number of acne and Global acne grading system scoring scale
研究概览
简要总结
Acne is estimated to affect 9.4% of the world’s population with the highest prevalence in adolescents. It is a chronic condition affecting more than 85% of adolescents, aged 12-25 years and two-third of adults aged 18 years and older. Acne, often perceived as a mere cosmetic issue, can have profound and lasting emotional and psychological impacts. Many creams, oils, and topical preparations are available for the management of acne, but they only provide temporary effects. However, these have been proven to be less effective. A combination of Manjishthadi oil nasya and Lodhradi lepa would be beneficial for Acne. Nasya treatment can have a long-term and prompt effect on Acne by correcting vitiated doshas, along with local symptoms will be reduced by Lepa treatment. Hence present study is taken to find an effective and safe management for Acne.
Primary objective - To compare the efficacy of Lodhradi lepa and Manjishthadi taila Marsha nasya with Lodhradi lepa in the management of Acne.
Secondary objective- To observe adverse effects if any.
Methodology -
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Study design - Randomised comparative clinical trial.
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Study Setting - Location -OPD and IPD Participants of concerned Institutes.
Duration of study - 36 months
Duration of treatment- 7 days with follow-up on 8th &15th day.
- Study population - 108 Participants of age group 13-30 years of either gender showing classical sign and symptoms of Acne.
Group A - Manjishthadi taila Marsh nasya with Lodhradi lepa for 7 days
Group B- Lodhradi lepa for 7 days.
Data Analysis - Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervention on the primary and secondary outcomes.
Ethical consideration- The study will be conducted with ethical guidelines and with informed consent from participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 13.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participant having Mild to Moderate Acne Vulgaris.
- •2.Participants will be selected irrespective of sex, religion, occupation with age between 13 to 30 years.
- •3.Acne affecting the face.
- •4.Participants Arha for Nasya and lepa karma.
排除标准
- •1.Drug induced acne i.e. Participants receiving systemic steroids, hormonal therapies, or antibiotics.
- •2.Participant having acne on other than face.
- •3.Participant having local wound or infection.
- •4.Participant having nodular or cystic acne & any other type of acne than Acne vulgaris.
- •5.Participant suffering from autoimmune disorders like SLE, immunological deficiencies, uncontrolled metabolic disorders like D.M., pregnant & lactating woman.
结局指标
主要结局
Changes in clinical features like pain, itching, burning ,number of acne and Global acne grading system scoring scale
时间窗: Duration of study–36 months | Duration of treatment: 7 days with follow-up on | 8th and 15th day
次要结局
- To study adverse effects if any(Duration of study–36 months)
研究者
Dr Priya Bangar
Center for Post Graduate Studies and Research in Ayurved, Tilak Ayurved College