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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/050486

Enrollment

Registered

2023-03-09

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E08-E13- Diabetes mellitus

Interventions

None listed

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Subject diagnosed with type 1 Diabetes. 2. Subjects with Haemoglobin percentage 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. 10. Subjects with a current diagnosis of malignancy or in the last five years. 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.

Design outcomes

Primary

Measure	Time frame
1.Change in serum glucose levels from baseline to 84 days.Timepoint: 1.Change in serum glucose levels from baseline to 84 days.	—

Secondary

Measure	Time frame
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. Timepoint: 1.Change in HbA1C, FBS, PPBS, Haematology at Baseline, 84th day 2.Change in BMI, Waist circumference at Baseline , 84th day 3.Change in Diabetes Symptoms Questionnaire (DSQ)at Baseline, 28, 56, 84th day 4.Any SAE/ADR at 28, 56, 84th day 5. Treatment Compliance at 28, 56, 84th day	—

Measure

Time frame

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. Timepoint: 1.Change in HbA1C, FBS, PPBS, Haematology at Baseline, 84th day 2.Change in BMI, Waist circumference at Baseline , 84th day 3.Change in Diabetes Symptoms Questionnaire (DSQ)at Baseline, 28, 56, 84th day 4.Any SAE/ADR at 28, 56, 84th day 5. Treatment Compliance at 28, 56, 84th day

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Countries

India

Contacts

Public ContactDr Chandini Chandrasekharan NP

Central Ayurveda Research Institute

kpmonicajune@gmail.com7411338556

Outcome results