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Effect of ayurvedic drug KAL-10 on diabetes and related conditions

Effect of ayurvedic drug KAL-10 on lowering hyperglycemic in subjects with diabetes: A Randomized Placebo Controlled trial.

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010856
Enrollment
100
Registered
2017-12-13
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: KAL-10: Ayurvedic drug, KAL-10 (600 mg) capsule twice daily for 12 weeks, oral route Intervention2: KAL 10 Plus: Ayurvedic drug, 650 mg capsule twice daily for 12 weeks, oral route Cont

Sponsors

Kerala Ayurveda Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Informed consent obtained before any trial-related activities Male or female patients between 18 to 70 years of age Newly diagnosed with hyperglycemia FBS�110 mg/dL but �200 mg/dL, measured on day-1 PPBS >120 mg/dL and � 200 mg/dL HbA1c 6% � & � 10% C peptide � 1.0 ng/ml Ability to comply with study requirements

Exclusion criteria

Exclusion criteria: Females who are pregnant and/or lactating and/or sexually active but not using an acceptable method of contraception History of allergy or contraindications to the ingredients present in the drug History of uncontrolled or poorly controlled serum cholesterol Renal impairment/insufficiency (i.e., nephritis, polycystic kidney disease, acute or chronic renal failure, end stage renal disease, >1.5 times the upper limit of normal (ULN) of serum Creatinine, etc.) AST, ALT >3 times the ULN Thyroid dysfunction Gastrointestinal disorders (ulcerative colitis, etc.) Hepatic impairment/ acute liver disease or persistent elevations in liver function tests (3 times the upper limit of normal (ULN) of LFT Uncontrolled hypertension, as defined by SBP >160 mmHg or DBP >100 mmHg while on anti-hypertensive medication

Design outcomes

Primary

MeasureTime frame
Statistically significant reduction in fasting blood glucose Reduction in total triglyceride Reduction in postprandial blood glucose level from the baseline Decrease in HbA1c levels Improvement in Insulin sensitivity C-PeptideTimepoint: Base line Visit (visit-1) (Day 0) 2nd interim visits (visit 2) (Day 30) 3rd interim visits (visit -3) (Day 60) Last visit (visit-4) (Day 90)—

Secondary

MeasureTime frame
Reduction in Cholesterol and LDL levels Improvement in HDL levels Clinical chemistryTimepoint: Base line Visit (visit -1) (Day 0) Last visit (visit-4) (Day 90)—

Countries

India

Contacts

Public ContactJayashree M
jayashree@katraphyto.com9880677814

Outcome results

None listed

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