FindTrial
Sign In

A CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DIABOHERB IN PATIENTS WITH TYPE 2 DIABETES MELLITUS.

A PROSPECTIVE, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF DIABOHERB IN PATIENTS WITH TYPE 2 DIABETES MELLITUS.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/12/005286
Enrollment
150
Registered
2014-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: E11- Type 2 diabetes mellitus

Interventions

Intervention1: Diaboherb1: One tea spoon at each time three times daily half an hour before food for 90days Intervention2: Diaboherb2: One tea spoon at each time three times daily half an hour before

Sponsors

SBL PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Males & Females Patients with Type 2 Diabetes Mellitus with age 30â??65 year • Only new cases with inadequate glucose control • Body mass index between 20-35 kg/m2 • Having fasting blood glucose > 126 mg/dL • Post prandial blood glucose > 200 mg/dL • Having no serious Physical abnormalities other than those generally associated with type 2 Diabetes Mellitus. • Patient is willing and able to comply with all trial requirements • Ability to understand the Informed Consent and Willing to Sign on informed consent along with audio video visual in accordance with GCP and local legislation • Patients able to understand and follow the protocol of the trial. • Participants who are able to visit the medical institutions throughout the study period

Exclusion criteria

Exclusion criteria: • Patients having Insulin dependent Diabetes Mellitus. • Having history of hypersensitivity, liver or kidney damage or gastrointestinal disorders, acute infections, diseases of blood or hematopoietic organs • Pregnant or lactating women • Patients receiving any concomitant medication, which may have interacted with hypoglycemic action of study drug • Previous participation in a clinical trial in the last 6 months. • Subjects who are already taking or have taken in the past 2 months any investigational drug. • Dehydration by clinical judgement of the investigator. • Any contraindication to blood sampling. • Severe asthma that is poorly controlled with medication. • Significant psychiatric illness, senility, dementia.

Design outcomes

Primary

MeasureTime frame
Changes in Diabetic Panel InvestigationsTimepoint: Changes in Diabetic Panel Investigations—

Secondary

MeasureTime frame
â?¢ Incidence and rate of adverse events â?¢ Quality of life questionnaire before and after the treatment( SF-36 HEALTH SURVEY ) Timepoint: Screening to EOT (Day 90)—

Countries

India

Contacts

Public ContactDr Harisha S

ICBio Clinical research Pvt Ltd

harish@icbiocro.com9900111997

Outcome results

None listed

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