Date

2022-11-28

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Participants will be recruited from the Rural Ayurvedic Hospital,Karaveddy and the Government Siddha Ayurvedic medical Clinics functioning under Vadamarachi South West Piradesha sabba, Jaffna District. The interventional product will be prepared according to the Siddha pharmacopeia (P. Ramanathan, 2000). The collected leaves of Gymnema sylvestre (Small Indian ipecacuanha), Murraya keonigii (Curryleaf), ripe fruit of Pyllanthus emblica (Indian gooseberry) without seed and skin of the Terminalia chebulla (Chebulic Myrobalam) seed. The components will be dried thoroughly under shade and powdered. The powdered materials will be sieved up to 60/80 meshes and stored in an air tight container. The maximum prescribed dose is 5g twice a day to be consumed with hot water after meals. The dose will be titrated according to the blood glucose level (if blood glucose <200mg/dl, 5g of the product to be taken once daily and if blood glucose is >200mg/dl, 5g of the product to be taken twice daily). Total duration of treatment is 3 months. Subjects will be requested not to seek therapy from any other alternative medicinal system (allopathic, homeopathy, acupuncture, and acupressure etc).

Next Version

The interventional product was prepared according to the Siddha pharmacopeia(P.Ramanathan, 2000) Fresh leaves of G. lactiferum and M. koenigii, were cleaned, washed and dried under shade at room temperature for 5 days. Seed coats of the T. chebula and fruit of P. emblica were cleaned, washed and dried under shade at room temperature for 10 days. The individual parts were grinded by using mixer grinder and then sieved using sieve shaker and manually passed through 100 no. sieve and stored in airtight plastic containers. The powders of the seed coat of T. chebula, fruit of P. emblica, leaves of M. koenigii and leaves of G. lactiferum were mixed in 1:1:1:0.2 ratio with slight modification to the ratio reported by Ramanathan (2010) to prepare MMC. The clinical evaluation of MMC was conducted for a period of 12 weeks. The maximum prescribed dose was 2.5g twice a day, consumed with hot water before meals. Subjects were instructed not to seek therapy from any other alternative medicinal system such as allopathic, homeopathy, acupuncture, and acupressure and evaluation was made at base line and at 12 weeks of intervention with MMC. Blinding was not done as the biochemical values of baseline were compared with values after the trial. Outdoor patients seeking treatment only were included in the study. They were advised not to change their dietary and social habits.