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CARDIOVASCULAR EFFECT OF CINNAMON CAPSULES IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND HYPERTENSION

TO DETERMINE THE CARDIOVASCULAR EFFECT OF CINNAMON CAPSULES IN PATIENTS WITH TYPE 2 DIABETES MELLITUS AND HYPERTENSION A SINGLE-BLINDED RANDOMIZED CONTROL TRIAL (PILOT STUDY)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052601
Enrollment
40
Registered
2023-05-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: I10- Essential (primary) hypertension Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Cinnamon capsule: After qualitative and phytochemical analysis cinnamon extract will be converted into the capsule as per the standard recommended doses used in previous studies. Cinnam

Sponsors

Ajinkya Mukund Rahatgaonkar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Inclusion criteria Age 30-60 years Patients with type 2 diabetes mellitus based on ADA criteria. Patient with Hypertension Patients taking Oral hypoglycemic agents. HbA1C: > 7

Exclusion criteria

Exclusion criteria: Patient with prior history of an allergy to cinnamon Alcoholic liver disease (ALD), cirrhosis On insulin therapy Raised baseline serum creatinine levels ( >1.5 mg/dl in men or > 1.2 mg/dl in women) Lactation, pregnancy Patients with symptoms suggestive of peptic ulcer disease and those with a past history of peptic ulceration Any malignancy Patients with unrelated chronic illnesses and infections like Tuberculosis Patients with cardiac, liver, or respiratory failure. Patients with bleeding disorders and who are taking coumarin derivatives (e.g., warfarin) Patients diagnosed with Acute coronary syndrome (CAD- Prior history of MI, angina)

Design outcomes

Primary

MeasureTime frame
At the end of 12 weeks see the change in blood pressure, hs-CRP level, and Plasma homocysteine level.Timepoint: At the beginning of the study both groups will be analyzed for baseline Systolic and Diastolic Blood Pressure, CRPH, and plasma homocysteine level. Patients will be asked for follow-up after 12 weeks of treatment and repeat Systolic and Diastolic Blood Pressure, CRPH, Plasma homocysteine level will be measured

Secondary

MeasureTime frame
â?¢ AT the end of 12 weeks to see a change in HOMA-IR, glycemic control in the study group with the control group on standard therapy. Timepoint: At the beginning of the study, both groups will be analyzed for baseline HOMA-IR. Patients will be asked for follow-up after 12 weeks of treatment and repeat HOMA-IR level will be measured.

Countries

India

Contacts

Public ContactAjinkya Mukund Rahatgaonkar

AIIMS Rishikesh

ravi.med@aiimsrishikesh.edu.in07028843689

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026