Date

2018-09-26

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

The study will be carried out at the Diabetic Centre, Teaching Hospital Jaffna. The first patient will be selected by lottery from the first five patients according to the clinic numbers and then every fifth patient will be selected for screening. Consenting patients meeting the inclusion/exclusion criteria will be randomized into the intervention and control arms. Intervention arm: One cup of herbal tea, made from 1.5 gram Cherukurinja dry leaf powder tea bag, once in a day for three months. Control arm: One cup of green tea, made from 1.5 gram green tea bag, once in a day for three months. Standard anti-diabetic medication will be continued for all patients, in accordance with clinic protocols. Double blinding will be ensured as the participants will be treatment naive (not exposed to either Cherukurinja or green tea) and the outcomes will be assessed by investigators who will be blind to the treatment status.

Next Version

The study will be carried out at the Diabetic Centre, Teaching Hospital Jaffna. The first patient will be selected by lottery from the first four patients according to the clinic numbers and then every fifth patient will be selected for screening. Consenting patients meeting the inclusion/exclusion criteria will be randomized into the intervention and control arms. Intervention arm: One cup of herbal tea, made from 1.5 gram Cherukurinja dry leaf powder tea bag, once in a day for three months. Control arm: One cup of green tea, made from 1.5 gram green tea bag, once in a day for three months. Standard anti-diabetic medication will be continued for all patients, in accordance with clinic protocols. Double blinding will be ensured as the participants will be treatment naive (not exposed to either Cherukurinja or green tea) and the outcomes will be assessed by investigators who will be blind to the treatment status.