A Clinical Consensus study for developing Standard Operative Procedure and Practice Guidelines of Seka and Aschyotana of Netra Kriyakalpa with a Feasibility study in Conjunctivitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
研究概览
简要总结
kriyaklpas are the specilized local therapeutic (sthaniya chikitsa) procedures indicated for netraroga in various ocular conditions. As panchakarma therapy is important for kaychikitsa same as kriyakalpa therapy plays important role in treating various netraroga in shalakya . It includes Tarpana, Putapaka, Seka, Aschyotana, Anjana, Bidalaka and Pindi.Seka and Aschyotana, one of the frequent used kriyakalp therapy to cure netrarogas .Aschyotana is first line of treatment in eye diseases. Seka and Aschyotana both therapies are indicated in acute phase or aamavastha in eye diseases. The practice of seka and aschyotana varies across different parts of the country and among the practicing physicians. There lies the relevance of standardization of different aspects of seka and aschyotana procedure.
The purpose of the current study is to scientifically standardize the seka and aschyotana procedure in terms of purva ,pradhan and paschyat karma includes prepeartion of kwathdrvya with aseptic precaution, maintain temperature of prepared medicine, storage, time and dose in order to ensure safety and significantly increase procedural efficacy.
**Stage1: Clinical Consensus Study -**The RAND/UCLA Appropriateness Method (RAM) is indeed a widely recognized technique used to assess the appropriateness of medical and surgical interventions. It involves gathering expert opinions through a structured process to evaluate the appropriateness of specific healthcare procedures or treatments. The method involves a panel of experts who independently review and rate the appropriateness of specific medical procedures. Their opinions are then aggregated and analyzed to provide insights into the appropriateness of those interventions. This information can be used to develop standardized practice guidelines, improve healthcare quality, and inform decision-making in clinical settings. Two-Round Rating Process:
In the first round, panellists individually rate the appropriateness of medical procedures. There is no interaction among panellists during this phase.
In the second round, panel members come together for 1-2 days under the guidance of a moderator experienced in using the method. This face-to-face interaction allows for discussions and further clarification.
Stage 2: Feasibiltity Study-The feasibility and acceptability of the standardized procedures ofSeka and Aschyotana will be assessed by the procedure completion rate (proportion of participants who successfully complete the procedures as per protocol), protocol adherence rate (compliance with procedural steps and post-procedure care), and tolerability of the procedures, evaluated in terms of participant comfort, occurrence of adverse events, and overall acceptance from baseline to the end of the intervention period
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •1.Subjects of age 18-40 years 2.Subjects presenting with signs and symptoms of chronic allergic conjunctivitis 3.Subjects who agree to participate in the study and submit a written informed consent form 4.Willing and able to participate for 1 week.
排除标准
- •1.Participants having any complications with corneal involvement, conjunctivitis other than allergic, positive for conjunctival smear and culture, 2.disease of lachrymal system,genetic predisposition to allergy,concurrent co-morbid serious hepatic disorder, renal disorders, severe pulmonary dysfunction, 3.uncontrolled diabetes mellitus or poorly controlled hypertension 4.Uncontrolled diabetes mellitus and Uncontrolled hypertension 5.Subjects with concurrent Hepatic Dysfunction or Renal Dysfunction,uncontrolled Pulmonary Dysfunction.
- •6.pregnant or lactating females 7.patients on steroids, oral contraceptive pills, estrogen replacement therapy 8.smokers,alcoholics,drug abusers 9.patients on long-term drug treatment as in rheumatoid arthritis, psycho-neuro-endocrinal disorders 10.hypersensitivity to any of the ingredients of the trial drug 11.patients who have undergone any clinical trial during past 6 months were excluded from the study.
- •12.Any other condition which the Investigator thinks may jeopardize the study.
- •13.Subjects who refuse to participate in the study.
研究者
Dr Kamble Pallavi Namdev
Regional Ayurveda Research Institute Lucknow