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A clinical study on Oorithalthaamarai Chooranam in the management of Madhumegha noi muthalavathu Avasthai

A Prospective Open Labelled non randomized phase II Clinical study On Oorithalthaamarai Chooranam in the management of Madhumegha noi muthalavathu avasthai â?? parutha udal (Diabetic Dyslipidemia)

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030756
Enrollment
60
Registered
2021-01-27
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: E116- Type 2 diabetes mellitus with other specified complications

Interventions

Intervention1: Oorithalthaamarai Chooranam: 30 mg/kg/BW/twice a day A/F 90 Days Control Intervention1: NIL: NIL

Sponsors

OPD and IPD facilities and Central Library Government Siddha Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus 2. If yes in any of three As per ADA a. FBS - > 126mg/dl and b. PPBS - >140mg/d land c. HbA1c > 6.5 3. Secondary hyperlipidemia, Dyslipidemia has values as per NCEP a. Total cholesterol - >199 mg/dl or b. LDL - >100-129mg/dl or c. Triglycerides - >150-199 mg/dl. d. HDL level - 4. Willing to give blood sample for the investigations

Exclusion criteria

Exclusion criteria: 1.If yes in any one of three a. FBS - b. PPBS - 2.High lipid profile, dyslipidemia has values of, a. Total cholesterol b. LDL c. Triglycerides d. HDL level ->=50-60 mg /dl 3.Type 1 diabetes mellitus 4.Severe Hypertension 5.Pregnancy 6.Lactating mother 7.Chronic kidney disease / Renal failure 8.Chronic active viral hepatitis/cirrhosis/ascites

Design outcomes

Primary

MeasureTime frame
During treatment or after treatment, FBS became 110mg /dl & PPBS160mg/dl and HbA1c 6.5. Total cholesterol 199 mg/dl, LDL 159 mg/ dl and Triglycerides 150 mg/dl Timepoint: 90 days

Secondary

MeasureTime frame
1.Evaluation of safety profile for acute& sub acute toxicity of the trial drug. 2.Evaluation of primary phytochemical analysis in different solvents. 3.Evaluation of pharmacological activities including anti-oxidant property of the trial drug. 4.Evaluation of anti microbial activity in different solvents of the clinical trial drug. 5.To develop clinical documents and literary evidence to support the effect of trial drug. Timepoint: 90 days

Countries

India

Contacts

Public ContactDr A Manoharan MD PhD

Government Siddha Medical College and Hospital Palayamkottai

drmanoharan25@gmail.com9443886700

Outcome results

None listed

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