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临床试验/CTRI/2026/03/106415
CTRI/2026/03/106415尚未招募3 期

A Randomized Controlled Trial to study the efficacy of Rasanjanadi Bidalaka and Olopatadine eye drop in Vataja Abhishyanda with reference to Allergic Conjunctivitis

Sane Guruji Arogya Kendra1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年4月15日最近更新:
适应症
相关药物

试验速览

阶段
3 期
状态
尚未招募
入组人数
62
试验地点
1
主要终点
Symptoms like Toda (Pricking sensation),

研究概览

简要总结

This study aims to evaluate and compare the efficacy of Rasanjanadi Bidalaka, an Ayurvedic topical formulation, and Olopatadine eye drops, a commonly used modern anti-allergic medication, in the management of Vataja Abhishyanda with reference to allergic conjunctivitis. Allergic conjunctivitis is a prevalent ocular condition characterized by symptoms such as itching, redness, watering, foreign body sensation, and photophobia, which significantly affect patient comfort and quality of life. In Ayurvedic literature, Vataja Abhishyanda is described as an ocular disorder with clinical features that closely resemble allergic conjunctivitis, and it is managed through various local therapeutic measures including Bidalaka (application of medicated paste over the eyelids).

This randomized controlled trial is designed to assess the therapeutic effectiveness of Rasanjanadi Bidalaka in comparison with Olopatadine eye drops in reducing the clinical signs and symptoms associated with the condition. Eligible participants diagnosed with Vataja Abhishyanda/allergic conjunctivitis will be randomly allocated into two groups. One group will receive Rasanjanadi Bidalaka as a local Ayurvedic treatment, while the other group will be treated with Olopatadine eye drops as per standard ophthalmic practice. Clinical evaluation will be performed using predefined subjective and objective parameters such as itching, redness, watering, burning sensation, and conjunctival congestion. The changes in symptom severity before and after treatment will be assessed using appropriate scoring systems and statistical analysis to determine the significance of therapeutic outcomes.

The study seeks to explore the potential of a classical Ayurvedic external therapy as an effective and safe alternative or complementary approach in the management of allergic conjunctivitis. By comparing the outcomes with a widely accepted modern pharmacological agent, the trial aims to generate evidence regarding the clinical utility of Rasanjanadi Bidalaka and contribute to the integration of traditional Ayurvedic practices with contemporary ophthalmic care. The findings of this research may help in establishing an economical and accessible treatment option for patients suffering from allergic conjunctivitis while also validating Ayurvedic concepts in the management of ocular disorders

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
19.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •Individuals experiencing Vataja Abhishyanda, characterized by symptoms such as Toda (Pricking sensation), Sangharsha (Itching sensation), Shishirashruta (Cold lacrimation), and Alpa Shopha (Chemosis).
  • •Age: 19-60 years c.
  • •Irrespective of gender.

排除标准

  • •Any significant ocular infections, including corneal ulcers.
  • •Pregnant and lactating women.
  • •Acute keratoconjunctivitis, vernal keratoconjunctivitis, and giant papillary conjunctivitis.

结局指标

主要结局

Symptoms like Toda (Pricking sensation),

时间窗: Follow up on 3rd, 7th and 8th day

Sangharsha (Foreign body sensation), Achchasruta (Watery discharge), Alpa Shopha (Chemosis), Vishushka Bhava (Feeling of dryness) wil be decreased.

时间窗: Follow up on 3rd, 7th and 8th day

次要结局

未报告次要终点

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Kanchan Krishnath Devkate

MAMs Sumatibhai Shah Ayurved Mahavidyalaya

研究点 (1)

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