Evaluation of Comparative Efficacy of Haritkyadi Ointment with Guduchi Ghan Vati Versus White paraffin with Tablet Methotrexate in the Management of Ekakustha-A Randomized Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Haritkyadi Ointment and Guduchi Ghan Vati will reduce subjective assessment criteria like Aswedanam,Mahavastum,Matsyashakalopamam , Krishhna Arun Varnata in 8 weeks.
研究概览
简要总结
The Volunteers will be informed about the study protocol. Willing participants will be randomly selected as per computerized generated table . Clinical research format will be prepared and validated .Prior to study approval will be taken from IEC ,MGACHRC,Salod (H) Wardha and CTRI registeration will be done .After selection each participants will be tested individually and selected according to Inclusion criteria .They are divided into two groups .The trial is Randomized Open Labelled Controlled Trial . it will include a 60 days treatment period and follow up on 15th ,30th ,45th ,60th day
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing to participate with written informed consent Patient between the age group of 18 to 60 years of either Sex With moderate to severe Psoriasis with PASI score greater than 10 and willing to participate in the study.
- •Patient having clinical feature of Ekakushtha i.e. of Aswedana, which means dry and rough lesions, Mahavastu, which covers the entire body, Matsyashakalawat is well demarked raised patches with large silvery loose scaling (skin resembles scales of fish), and Krishna-Aruna Varnata (blackish in color).
排除标准
- •Chronic cases of Psoriasis more than 5 years.
- •Known case of Diabetes, Cancer, AIDS, Tuberculosis And Nervous System, Renal, Hepatic, Endocrine, Gastrointestinal, or Pulmonary Disease Pregnant or Lactating Women.
- •Subjects with other dermatological infectious conditions.
- •Major surgical procedure within 28 days prior to randomization.
- •Any condition that in opinion of the investigator, does not justify the patient participation.
结局指标
主要结局
Haritkyadi Ointment and Guduchi Ghan Vati will reduce subjective assessment criteria like Aswedanam,Mahavastum,Matsyashakalopamam , Krishhna Arun Varnata in 8 weeks.
时间窗: Haritkyadi Ointment and Guduchi Ghan Vati will reduce subjective assessment criteria like Aswedanam,Mahavastum,Matsyashakalopamam , Krishhna Arun Varnata in 8 weeks.
次要结局
- Immunity Boosting(60 days)
研究者
Dr Nidhi Shetiya
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod (H) Wardha Maharashtra