A clinical study to see the effect of an Ayurvedic formulation in the treatment of Conjunctivitis.

Phase 2

Completed

Conditions: Allergic Conjunctivitis

Registration Number: CTRI/2012/01/002375

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. This present clinical trial on Allergic Conjunctivitis is one of these eighteen clinical trials.

**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 Allergic Conjunctivitis 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 150

Inclusion Criteria

Patients of either sex aged between 16-35years.
Patients presenting with signs and symptoms of Allergic Conjunctivitis.
Willing and able to participate for 16 weeks.

Exclusion Criteria

1. Patients having complications like marginal corneal ulcer, dacryocystitis, trachoma, kerato.
conjunctivitis, Infective conjunctivitis, etc. 2. Patients having genetic predisposition to allergy. 3. 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. 4. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%) 5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg) 6. Pregnant / lactating females 7. Patients on steroids, oral contraceptive pills or estrogen replacement therapy. 8. Smokers/Alcoholics and/or drug abusers 9. Patients with evidence of malignancy 10. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro- Endocrinal disorders, etc.) 11. H/o hypersensitivity to the trial drug or any of its ingredients. 12. Patients who have completed participation in any other clinical trial during the past six (06) months. 13. Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ïƒ˜ Symptomatic improvement.	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

Trial Locations

Locations (3): Government Ayurveda College, Thiruvananthapuram
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Thiruvananthapuram, KERALA, India
Institute of Post-Graduate Training & Research in Ayurveda (IPGT&RA), Jamnagar
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Jamnagar, GUJARAT, India
Shri Dharmasthala Manjunatheswara (SDM) College of Ayurveda, Hassan
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Hassan, KARNATAKA, India
Government Ayurveda College, Thiruvananthapuram
🇮🇳Thiruvananthapuram, KERALA, India
DrSubhadra Antharjanam DrCMJimin
Principal investigator
9446479059
drsubhadrapotty@yahoo.com