跳至主要内容
临床试验/CTRI/2026/01/101864
CTRI/2026/01/101864尚未招募不适用

A Clinical Consensus study for developing the practice guidelines and Standardization of Tarpana & Putapaka with a Feasibility study in Myopia

Central Council for Research in Ayurvedic Sciences CCRAS4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年5月1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
4

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 eyes. They comprise procedures such as Tarpana (retention of medicated ghee), Putapaka (retention of extracts of medicinal plants), Seka (medicated solution poured as stream), Aschyotana (eye drops), Anjana (ointments), Pindi and Bidalaka (external application on the eyelids 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 order to avoid any untoward effects and to obtain the optimum outcome. The Ocular therapeutics such as Tarpanaand Putapaka mentioned in Ayurveda Samhita’s differs in factors such as dosage form, consistency of medicine temperature, retention time of medicines, the height of administration, safety instructions, quality indicators, and therapeutic benefit evaluation. Standardization is required to ensure uniformity in the quality and integrity of the procedures. Hence there is need of hour for development of critical guidelines for kriyakalpa procedures like Tarpana and Putapaka in terms of dosage form, temperature, time, height, quality, and feasibility in order to promote consistent practice.

This study is done in 2 stages,

Stage 1 is Clinical consensus study to to develop standard operative procedure and practice guidelines for Tarpana & Putapaka kriyakalpa procedure using the RAND/UCLA Appropriateness Method (RAM) which 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. In RAM, panellists rate the scenarios in a two-round “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 reaching a consensus. The "Modified" Delphi method 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 appropriateness of medical procedures. There is no 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 the method. This face-to-face interaction allows for discussions and further clarification.

     Stage 2 is the Feasibility study where Feasibility of Tarpana and Putapaka procedure with standardized dose, duration and procedure at OPD level, CARI, Bengaluru, CARI, New Delhi, RARI, Lucknow and NARIP, Cheruthuruthy (4 centres of CCRAS) is done with the objective to assess the feasibility and acceptability of the standardized procedure of Tarpana and Putapaka in in Myopia with Mahatriphaladya Ghrita.

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

  • Subjects of age 18-40 years
  • Subjects presenting with Avyakta Darshana or blurring of vision for distance
  • Subjects diagnosed with low to modest degrees of myopia (0 to minus 6 diopters)
  • Subjects who agree to participate in the study and submit a written informed consent form
  • Willing and able to participate for 9 days.

排除标准

  • 未提供

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 Bhavya B M

Central Ayurveda Research Institute, Bengaluru

研究点 (4)

Loading locations...

相似试验