A study of Rohitakadi Vati in management of type-2 Diabetes Mellitus.

Phase 2

Not yet recruiting

Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,

Brief Summary: This is single blind, parallel group, randomized placebo controlled trial on Type 2 Diabetes Mellitus patients with special reference to Prameha. Study will be conducted at Shree Saptashrungi Ayurveda Mahavidyalaya and Hospital, Nashik. 200 patients of known cases of Type 2 Diabetes Mellitus, from age group 30 years to 60 years will be selected randomly. Out of 200 patients, 100 patients will be allocated to the trial group and 100 patients will be allocated to the controll group. Trial group will receive Tablet Rohitakadi Vati, 1 g, two times a day, before food,for 90 days and control group will receive placebo for 90 days. Subjective parameters will be assessed every 15 days for 90 days. Objective parameters such as Blood sugar levels, HbA1C, Urine sugar will be assessed at the beginning of trial and after 90 days. Statistical analysis will be done by using appropriate statistical test such as Wilcoxon sign rank test for subjective parameters and paired and unpaired â€™tâ€™ test for objective parameters. Conclusion will be drawn based on observation, results and discussion.

Recruitment & Eligibility

Inclusion Criteria

1. Confirmed diagnosis of type-2 diabetes mellitus according to American Diabetes Association criteria.
1. Fasting glucose level between 125 to 200 mg/dL, Post prandial blood sugar level 200 to 280 mg/dL.
1. HbA1c level between 6.4 to 7.5 %.

Exclusion Criteria

1. Type-1 diabetes mellitus 2) Gestational diabetes 3) Patient with type 2 diabetes mellitus below age 30 years and above age 60 years.
1. Patients with fasting sugar more than 200 mg/dL and post prandial more than 280 mg/dL will be excluded from study.
1. Pregnancy or breastfeeding.
1. History of severe diabetic complications, such as diabetic ketoacidosis.
1. Patients with history of severe liver, kidney or heart disease.
1. Patients having any other life threatening disease.

Primary Outcome Measures

Name	Time	Method
Fasting Blood Sugar (FBS)	90 days
Post Prandial Blood Sugar (PPBS)	90 days
Glycosylated Hb (HbA1c)	90 days
Urine Sugar	90 days

Secondary Outcome Measures

Name	Time	Method
Polyuria, Polydipsia, Polyphagia, Tiredness, Hyperhidrosis, Dryness of mouth, Burning sensation in Hands & Feet.	Every 15 days for 90 days

Locations (1): Shree Saptashrungi Ayurved Mahavidyalay and Hospital
🇮🇳
Nashik, MAHARASHTRA, India
Shree Saptashrungi Ayurved Mahavidyalay and Hospital
🇮🇳Nashik, MAHARASHTRA, India
Dr Mohit Pandit
Principal investigator
9823815199
dr.mohitayu@gmail.com