A Randomized Clinical Trial To Evaluate The Efficacy of Dhatrayadi Rasakriya and Triphaladi Ghana Vati In Kacha With Special Reference To Immature Senile Cataract
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Changes in best corrected visual acuity
研究概览
简要总结
Variousmedicines are mentioned in Ayurvedic classics for vision care and prevention ofcataract. Among these lekhana Anjana is one of the topical treatments used in kacha.Considering this point, Dhatrayadi Rasakriya Anjana was selected. It contains Amalaki,Rasanjana, Madhu and Ghrita, having the lekhaneeya and kaphaghna properties. Itis indicated in Timira and Patalagata Rogas, also suitable for the managementof Kacha. Triphaladi Churna is mentioned by Acharya Yogaratnakara in themanagement of Kacha. It contains drugs with chakshusya, and Rasayana actionlike Amalaki, Haritaki, Vibhitaki, Yastimadhu and Lauha Bhasma.
NEEDFOR STUDY Cataract is the world leading cause of blindness affecting usually inadults aged above 50 years as per data published in 2020, with over 15 millionindividuals contributing to 45 percent of 33·6 million cases of globalblindness. Till date no accepted medical treatment is available for cataract,surgery is the only available treatment for cataract. Therefore, the entireworld is looking at the other systems of medicine to tackle the situation andlooking upon preventive ophthalmology for improving and maintaining vision
RESEARCH QUESTIONWhether Dhatrayadi Rasakriya with or without Triphaladi Ghana Vati are equally effective in Kacha w.s.r. to Immature Senile Cataract?
HYPOTHESIS
Null Hypothesis: Ho - There is no difference in the effect of Dhatrayadi Rasakriya with or without Triphaladi Ghana Vati in Kacha.
Alternative Hypothesis: H1 - There is difference in the effect of Dhatrayadi Rasakriya with or without Triphaladi Ghana Vati in Kacha.
AIMSAND OBJECTIVES
AIM
To evaluate the effect of Dhatrayadi Rasakriyawith or without Triphaladi Ghana Vati in Kacha w.s.r to Immature SenileCataract.
OBJECTIVES
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To evaluate the effect of DhatrayadiRasakriya with Triphaladi Ghana Vati in signs and symptoms of Kacha w.s.r toImmature Senile Cataract.
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To evaluate the effect of DhatrayadiRasakriya in signs and symptoms of Kacha w.s.r. to Immature Senile Cataract.
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To evaluate the changes in Cataract GradingClassification as per LOCS III.
GROUPING OF PATIENTS :
Group A- This group will be treated with Dhatrayadi Rasakriya topically along withTriphaladi Ghana Vati orally for 45 days (Trial Group A)
Group B- This group will be treated with only Dhatrayadi Rasakriya topically for 45 days (Trial group B)
ASSESSMENT CRITERIA:
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Avyakta Darshana (Durastha and Samipastha)
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Glare
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Visualization of nonexisting thing like dots, lines, threads.
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Best Corrected Visual Acuity for distance using Snellen’s chart
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Best Corrected Visual Acuity for near using Jaeger’s Eye chart 6. Slit lamp examination with photography (if applicable)
LOCS III cataract Grading will be followed for grading the cataract on the basis of slit lamp findings.
Laboratory Investigation-
• CBC
• RBS
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
- 40.00 Day(s) 至 70.00 Day(s)（—）
- 性别
- All
入选标准
- •Age: 40-70 years 2) Patients having specific signs and symptoms of Kacha (Immature Cortical and Posterior Subcapsular Senile Cataract) 3) Patients with visual acuity 6/9 or less 4) Patients of either gender.
排除标准
- •Senile Mature and Hyper Mature Cataract 2) Visual acuity of less than 6/60 3) Congenital, developmental, traumatic, complicated and metabolic cataract.
- •Any other ocular pathology that can cause diminution of vision.
- •Any other systemic illness like HTN, DM 6) Person undergoing treatment for any other serious illness.
- •Patient unwilling to participate in the trial.
结局指标
主要结局
Changes in best corrected visual acuity
时间窗: At baseline day and after completion of trail
次要结局
- Changes in Cataract Grading Classification as per LOCS III(At baseline day and after completion of trail)