A COMPARATIVE CLINICAL TRIAL TO ASSESS THE EFFICACY OF LODHRADI SERUM AND LODHRADI LEPA IN YUVANPIDIKA
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
研究概览
简要总结
This study is a comparative, prospective, interventional Phase II clinical trial designed to evaluate and compare the efficacy of Lodhradi Serum and Lodhradi Lepa along with Manjistha Ghan Vati in the management of Yuvanpidika (acne vulgaris)
Yuvanpidika is described in classical Ayurvedic texts such as Sushruta Samhita and Charaka Samhita as a Kapha-Vata-Rakta predominant disorder characterized by Shalmali-kantaka-like eruptions, pain (Saruja), hardness (Ghana), and Medogarbha (sebaceous content). Manjistha is mentioned under Varnya Mahakashaya in Charaka Samhita and is selected for its Raktashodhaka and Varnya properties
A total of 60 patients (18–40 years) diagnosed with Yuvanpidika will be randomly divided into two groups:
Group A: Lodhradi Serum (local application once daily) + Manjistha Ghan Vati 500 mg twice daily
Group B: Lodhradi Lepa (½ Angula thickness, once daily) + Manjistha Ghan Vati 500 mg twice daily
The duration of treatment will be 60 days, with follow-up assessments every 15 days
Primary OutcomeAssessment of difference in efficacy between the two groups using the Global Acne Grading System (GAGS) score.Secondary OutcomesAssessment based on subjective parameters includingPidika (eruption)Kandu (itching)Ruja (pain)Daha (burning sensation)Shrava (discharge)Snigdhata (oiliness)Vaivarnya (scarring)Statistical analysis will include descriptive statistics and inferential tests such as the Wilcoxon signed-rank test and Mann–Whitney U test
The study will be conducted at the National Institute of Ayurveda, Jaipur, after obtaining ethical approval and registration with the Clinical Trial Registry of India (CTRI).
The aim of the study is to determine whether the novel dosage form (Lodhradi Serum) offers superior therapeutic efficacy compared to the classical Lodhradi Lepa in the management of Yuvanpidika
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
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with classical signs and symptoms(such as Shalmali Kantakprakhya,saruja,Ghana,Medogarbha) of Yuvanpidika Subjects ready to give informed written consent for the trial.
排除标准
- •Known case of any acute/chronic skin diseases.
- •Known cases of Systemic diseases or Metabolic disorders Subjects taking medication for any physical or psychological condition Pregnant or lactating women Regular smokers or alcohol users.
研究者
RENU KUMARI YOGI
National Institute Of Ayurveda