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临床试验/CTRI/2023/04/051677
CTRI/2023/04/051677尚未招募3 期

Efficacy Of Shigru-Haridradi Aschyotana (Eye Drop) with Haridrakhanda and Bilvadi Aschyotana with Haridrakhanda in the Management of Vataja Abhishyanda (Simple Allergic Conjunctivitis) - An Open Labelled Randomized Comparative Clinical Trial.

Institute of Teaching and Research in Ayurveda1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年1月5日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Relief in Subjective and Objective Criteria of Vataja Abhishyanda (Simple Allergic Conjunctivitis).

研究概览

简要总结

**Introduction:**Conjunctival hyperemia or Conjunctivitis (inflammation of outermost layer of the eye and innermost layer of the eyelids) is the commonest eye disorder nowadays and among them Ocular allergy represents one of the most common conditions encountered by allergists and ophthalmologists. It has an equal distribution throughout the world, without any exception to the developed and under developed countries. It is categorized as infective and non-infective conjunctivitis. Simple Allergic Conjunctivitis is a non-infective type of conjunctivitis in which inflammation of conjunctiva occurs due to allergic or hypersensitive reactions by dust, pollen, air pollution and other environmental factor which may be immediate or delayed.**Significance:*Prevalence rate of Simple Allergic Conjunctivitis is 10% to 30% of the general population,Recurrence in 41-62% cases have an equal distribution throughout the world, without any exception to the developed and under developed countries.In the management of Simple Allergic Conjunctivitis most of the drugs are Anti-allergic and Immune-modulators areused. But both have temporary effects and high recurrence rate.So, to prove the efficacy there is need of Ayurvedic interventions like Aschyotana(Eye drop)therapy (alternative medicine) and Ayurvedic Anti-allergic oral medication which is devoid of side effects and reduce the recurrence rate of Vataja Abhishyanda(Simple Allergic Conjunctivitis).Materials and Methods:Minimum 30 patients will be enrolled on the basis of symptoms of Pricking Pain (Nistoda), Foreign body sensation (Sangharsh), Redness (Ragata), Dryness- Feeling (Vishushka Bhava), Clean /Watery discharge (Achchasruta), Mild Chemosis (Alpa Shopha) , Itching (Kandu), Burning sensation(Daha).*Group A Patients will receive  Shigru-Haridradi Aschyotana(Eye drop) along with Haridrakhanda and Group B Patients will receive Bilvadi Aschyotanaalong with *Haridrakhanda .***Results and Discussion:**Data generated during the above study will be presented in a systematic manner and shall be analysed statistically. **Follow up:**After completion of therapy, follow up will be done for 2 weeks to assess the status of patient, where patient will be asked to report fortnightly.Adverse effects: this proposal will be reviewed and approved by I.T.R.A. Institutional Ethical Committee , Which is having the responsibility to protect the research participants from harm. These drugs have no known unwanted effects . it is possible that it may also cause some problems that we are not aware of. Adverse Drug Reaction if any observed will be reported to the Pharmacovigilance cell of I.T.R.A.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients between 18 to 50 years of age.
  • 2.Patients having minimum three symptoms of Simple Allergic Conjunctivitis.

排除标准

  • 1.Patients below 18 years and above 50 years of age.
  • 2.Patients having complications of corneal involvement like Marginal Corneal Ulcer, Dacryocystitis, Trachoma, Keratoconjunctivitis sicca, Vernal Keratoconjunctivitis, Giant papillary conjunctivitis, Atopic Keratoconjunctivitis.
  • 3.All types of Conjunctivitis (Acute and Chronic) which are non-allergic in nature are excluded from the Study.

结局指标

主要结局

Relief in Subjective and Objective Criteria of Vataja Abhishyanda (Simple Allergic Conjunctivitis).

时间窗: 2 weeks

次要结局

  • Relief in Subjective and Objective Criteria of Vataja Abhishyanda (Simple Allergic Conjunctivitis).(4-6weeks)

研究者

发起方
Institute of Teaching and Research in Ayurveda
申办方类型
Research institution and hospital

研究点 (1)

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