A clinical study to see the effect of an Ayurvedic formulation in the treatment of Dry Eyes

Phase 2

Recruiting

• Conditions: Dry Eye Syndrome

• Registration Number: CTRI/2012/05/002639
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.

**Mahatriphaladya Ghrita** is a medicated semisolid poly-herbal formulation containing Haritaki (Terminalia chebula), Bibhitaki (Terminalia belerica), Amlaki (Emblica officinalis), Bhrngaraja (Eclipta alba), Vasa (Adhatoda vasica), Satavari (Asparagus racemosus), Guduci (Tinospora cordifolia), Pippali (Piper longum), Draksa (Vitis vinifera), Utpala (Nymphaea stellata), Madhuka (Glycyrrhiza glabra), Kantakari (Solanum xanthocarpum), Ksira kakoli (Fritillaria roylei), Aja kshira (goat milk) and Goghrta.

The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of **Mahatriphaladya Ghrita** - a classical Ayurvedic formulation. This formulation has been in use since ages and found to be useful in treating Dry Eye Syndrome and promoting the health.

The **Central Council for Research in Ayurvedic Sciences (CCRAS)** is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.

Similar clinical trial, being carried out as an Intra Mural Research (IMR) activity by CCRAS in its peripheral institutes has been registered with the Clinical Trials Registry, India (CTRI/2012/03/002532). The collective evidence generated during the A.C.T. project as well as the I.M.R. program would scientifically substantiate the clinical effect of the Mahatriphaladya Ghrita in the patients suffering from Dry Eye Syndrome.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-23
• Last Update Posted: 2012-04-23

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients of either sex aged between 35 to 70 years.
• Patients presenting with signs and symptoms of Dry eye syndrome.
•  Schirmer-I test positive i.e. < 10 mm.
•  Tear film break-up time less than 10 seconds.
•  Rose Bengal staining showing devitalized epithelium of conjunctiva and mucus plaques on the cornea.
• (If Any two of the above three criteria are present; the diagnosis of Dry Eye Syndrome is confirmed) 3.
• Willing and able to participate in the study for 16 weeks.

Exclusion Criteria

• Severe cases of dry eye syndrome with complications like perforated corneal ulcer, Uveitis, Glaucoma.
• Inflammatory conditions like acute conjunctivitis etc.
• Systemic diseases causing Dry Eye Syndrome.
• Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S.
• creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
• Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 6.
• Women who are pregnant or lactating 7.
• Patients on steroids, oral contraceptive pills, estrogen replacement therapy or any other medication that may adversely affect the outcome of the study 8.
• Smokers/Alcoholics and/or drug abusers 9.
• Patients with poorly controlled Hypertension ( >160/100 mm of Hg) 10.
• Patients with evidence of malignancy 11.
• Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.) 12.
• Patients who have completed participation in any other clinical trial during the past six (06) months.
• Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Change in the Clinical Parameters.	At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Secondary Outcome Measures

Name	Time	Method
1. Change in the Tear Film break up time	2. Change in Schirmer I Test

Trial Locations

Locations (3)

Government Ayurveda College, Thiruvananthapuram; 🇮🇳 Thiruvananthapuram, KERALA, India

Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar; 🇮🇳 Jamnagar, GUJARAT, India

Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan; 🇮🇳 Hassan, KARNATAKA, India

Government Ayurveda College, Thiruvananthapuram

🇮🇳Thiruvananthapuram, KERALA, India

DrSubhadra Antharjanam Dr A Shareef Ahamed

Principal investigator

9446479059

drsubhadrapotty@yahoo.com