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临床试验/CTRI/2026/01/102054
CTRI/2026/01/102054尚未招募不适用

A Clinical Consensus study for developing the practice guidelines and Standardization of Bidalaka with a Feasibility study in Abhisyanda

Central Council for Research in Ayurvedic Sciences CCRAS1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年2月24日最近更新:

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
1

研究概览

简要总结

Netra Kriyakalpa is a topical therapeutics performed in Ayurvedic ophthalmology. It involves a specific procedure using a prescribed formulation for proper application to the (retention of medicated ghee), Putapaka (retention of extracts of medicinal plants), Seka (medicated solution poured as stream), Aschyotana (eye drops), Anjana (ointments), Pi and adnexa). Ayurveda certainly recommends a number of methodological guidelines that are specifically designed in accordance with the stage, site and severity of the disease in optimum outcome. The Ocular therapeutics such as bidalaka mentioned in Ayurveda Samhita’s differs in factors such as dosage form, consistency of medicine the administration, safety instructions, quality indicators, and therapeutic benefit evaluation. Standardization is required to ensure uniformity in the quality and integrity of the proceed critical guidelines for kriyakalpa procedures like bidalaka in terms of dosage form, temperature, time, height, quality, and feasibility in order to promote consistent.

This study is done in 2 stages,

Stage 1 is Clinical consensus study to to develop standard operative procedure and practice guidelines for Bidalaka kriyakalpa procedure using the RAND/UCLA Appr recognized technique used to assess the appropriateness of medical and surgical interventions. It involves gathering expert opinions through a structured process to evaluate the 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 of those interventions. This information can be used to develop standardized practice guidelines, improve healthcare quality, and inform decision-making in clinical settings. I “Modified Delphi” process. This method is a structured communication technique that involves a group of experts providing feedback in a series of rounds, with the goal of re usually involves iterative rounds of feedback and may include face-to-face interactions. The two-Round Rating Process includes, in the first round, panellists individually rate the interaction among panellists during this phase. and in the second round, panel members come together for 1-2 days under the guidance of a moderator experienced in using discussions and further clarification. Stage 2 is the Feasibility study where Feasibility of Bidalaka  procedure with standardized dose, duration and procedure at OPD level, RARIM & MMR is  done with the objective to assess the feasibility and acceptability of the standardized procedure of Bidalaka in Abhisyanda

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
10.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects of age 10-60 years 2.Subjects presenting with swelling of eyelids due to inflammation.
  • 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.Subjects who have active corneal ulceration, corneal opacity, keratitis,trauma etc 2.Pregnant/ Lactating females 3.Alcoholics and/or drug abusers 4.Patients with evidence of malignancy 5.H/O Hypersensitivity to the trial drug or any of its ingredients 6.Subjects who have completed participation in any other clinical trial during the past six months.
  • 7.Any other condition which the Investigator thinks may jeopardize the study.
  • 8.Subjects who refuse to participate in the study.

研究者

发起方
Central Council for Research in Ayurvedic Sciences CCRAS
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Nandini Murli Jadhav

Regional Ayurveda Research Institute for Mineral and Marine Medicinal Resources Goa (RARIM&MMR)

研究点 (1)

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