To Evaluate The Efficacy of Dhatrayadi Rasakriya and Triphaladi Ghana Vati In Kacha With Special Reference To Immature Senile Cataract

Phase 2

Not yet recruiting

• Conditions: Other age-related cataract. Ayurveda Condition: KACAH,

• Registration Number: CTRI/2023/08/056376
• Lead Sponsor: National Institute of Ayurveda

Brief Summary

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

1) To evaluate the effect of DhatrayadiRasakriya with Triphaladi Ghana Vati in signs and symptoms of Kacha w.s.r toImmature Senile Cataract.

2) To evaluate the effect of DhatrayadiRasakriya in signs and symptoms of Kacha w.s.r. to Immature Senile Cataract.

3) 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:



1. Avyakta Darshana (Durastha and Samipastha)

2. Glare

3. Visualization of nonexisting thing like dots, lines, threads.

4. Best Corrected Visual Acuity for distance using Snellen’s chart

5. 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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-20
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. 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.

Exclusion Criteria

• 1. Senile Mature and Hyper Mature Cataract 2) Visual acuity of less than 6/60 3) Congenital, developmental, traumatic, complicated and metabolic cataract.
• 4. Any other ocular pathology that can cause diminution of vision.
• 5. Any other systemic illness like HTN, DM 6) Person undergoing treatment for any other serious illness.
• 7. Patient unwilling to participate in the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in best corrected visual acuity	At baseline day and after completion of trail

Secondary Outcome Measures

Name	Time	Method
Changes in Cataract Grading Classification as per LOCS III	At baseline day and after completion of trail

Trial Locations

Locations (1)

National Institute of Ayurveda Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

National Institute of Ayurveda Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Dr Nandini Miri

Principal investigator

9753815977

nandinimiri4@gmail.com