A pilot study to evaluate the role of Yoga capsule as add on in reducing serum glucose levels in diabetes.

Phase 2

Completed

Brief Summary: A glimpse at yoga books illustrates the daily practice of yoga can help in preventing diabetes, maintaining blood sugar levels in diabetics, and sidestepping the complications of diabetes. The practice of yoga requires a great amount of determination and time, which is difficult for a beginner. With a view of introducing diabetic patients to yoga, this abridged version of â€œYoga Capsuleâ€ which comprehends asanas and pranayamaâ€™s that are effective on diabetes has been devised in consultation with renounced experts. However, the study hopes at initiation of Yoga in patients of diabetes as a valid fragment of treatment protocol, to monitor the effect on serum glucose levels , BMI, waist circumference, changes in DS, this also validates the proposed Yoga Capsule in management of Diabetes as a potential life style modification.

Recruitment & Eligibility

Inclusion Criteria

1.Subjects of all gender, 18-60 years 2.Freshly diagnosed or known diabetic subjects with HbA1c of 5.7-9 % (both values included).
3.Subjects who agree to participate in the study and submit a written informed consent form.
4.Individuals physically fit to practice yoga protocol.

Exclusion Criteria

1.Subject diagnosed with type 1 Diabetes.
2.Subjects with Haemoglobin percentage < 8 g/dl.
3.Subjects with uncontrolled hypertension (with or without medication systolic >140 and/or diastolic >90 mmHg after 10 minutes of rest) 4.Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
5.Uncontrolled acute Pulmonary Dysfunction requiring inhalation or systemic steroids.
6.Pregnant / Lactating women.
7.Female subject of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy.
8.Subject who has undergone major surgical interventions in the past 2 years.
9.Subject on systemic or oral steroids, oral contraceptive pills or oestrogens replacement therapy.
11.Subjects suffering from major systemic illness necessitating long-term drug treatment (defined as more than 3 months).
12.Subjects who are not able to practice the yoga protocol.
13.Any other condition that the Investigator thinks may jeopardize the safety of the subject.

Primary Outcome Measures

Name	Time	Method
1.Change in serum glucose levels from baseline to 84 days.	1.Change in serum glucose levels from baseline to 84 days.

Secondary Outcome Measures

Name	Time	Method
1.Change in BMI and waist circumference at baseline & 84 days.	2.Change in Symptoms - Diabetes Symptoms Questionnaire (DSQ): At baseline, 28, 56 and 84days.

Locations (1): Central Ayurveda Research Institute
🇮🇳
Bangalore, KARNATAKA, India
Central Ayurveda Research Institute
🇮🇳Bangalore, KARNATAKA, India
Dr Monica KP
Principal investigator
7411338556
kpmonicajune@gmail.com