EFFECTIVENESS OF NEEDLE-PUNCTURE(VIDDHAKARMA) ALONG WITH ANTI-GLAUCOMA EYE-DROPS ON PAIN, VISION AND EYE-PRESSURE IN GLAUCOMA (KACHBINDU/ ADHIMANTHA).

Not yet recruiting

• Conditions: Unspecified glaucoma. Ayurveda Condition: ADHIMANTHAH,

• Registration Number: CTRI/2021/04/033120
• Lead Sponsor: Dr Chaitali Kulkarni

Brief Summary

TITLE:

A RANDOMIZED COMPARATIVE STUDY OF EFFECTIVENESS OF *VIDDHAKARMA* + ANTI-GLAUCOMATOUS EYE-DROPS VERSUS ANTI-GLAUCOMATOUS EYE-DROPS ALONE IN *ADHIMANTHA* WITH REFERENCE TO GLAUCOMA.



NULL HYPOTHESIS:

*Viddhakarma* + anti-glaucomatous eye-drops is equally effective as the anti-glaucomatous eye-drops alone on pain, IOP and visual acuity in *Adhimantha* w.r.t. Glaucoma.

ALTERNATE HYPOTHESIS: *Viddhakarma* + anti-glaucomatous eye-drops is more effective than anti-glaucomatous eye-drops alone on pain, IOP and visual acuity in *Adhimantha* w.r.t. Glaucoma.

The study will be conducted in a single centre and will include 48 eyes with symptoms of Adhimantha and Glaucoma. 24 eyes will be treated with Viddhakarma as an adjuvant therapy for 18 days (alternate days-10 sessions) along with anti-glaucomatous eye-drops and 24 eyes will be treated with anti-glaucomatous eye-drops alone for 18 days.



ASSESSMENT CRITERIA:



Subjective criteria:

Symptoms like:

*Netram nirmathyate vedana* (churning-like pain ineyes)

*Ardhashiraso vedana* (half-sided headache)

*Shankha Danta Kapoleshu Kapale Ruja* (pain in temporal region, teeth, cheek, forehead)

Ocular pain: Visual Analogue Scale (VAS)



Objective Criteria:

Visual Acuity

Intraocular pressure

Optic cup-disc ratio

Neuroretinal rim-disc ratio

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-05
• Last Update Posted: 2021-04-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• • Symptoms and signs of Adhimantha and Glaucoma like: 1.
• Netram nirmathyate vedana(churning-like pain in eyes) 2.
• Ardhashiraso vedana (half-sided headache) 3.
• Shankha Danta Kapoleshu Kapale Ruja (pain in temporal region, teeth, cheek, forehead).
• Intraocular pressure (IOP) greater than 20.6 mmHg. • Age group of 18-80 years.

Exclusion Criteria

• Below 18 years and above 80 years of age.
• Congenital glaucoma.
• Hatadhimantha (Absolute Glaucoma).
• Retinopathy due to any systemic disease.
• Any other ocular diseases related to the Central nervous system.
• 6.Pregnancy and lactation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ocular pain (VAS scale), Visual Acuity (LogMAR chart), Intraocular pressure (Schiotz tonometer)	follow up on 0, 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 33rd, 48th day

Secondary Outcome Measures

Name	Time	Method
Optic cup-disc ratio, Neuro-retinal rim-disc ratio	follow up on 0, 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 33rd, 48th day

Trial Locations

Locations (1)

Y.M.T. Ayurvedic Medical College and Hospital; 🇮🇳 Raigarh, MAHARASHTRA, India

Y.M.T. Ayurvedic Medical College and Hospital

🇮🇳Raigarh, MAHARASHTRA, India

Dr Chaitali Kulkarni

Principal investigator

9757398266

ckkulkarni512@gmail.com