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

Phase 2

Completed

• Conditions: Type 2 diabetes mellitus with other specified complications,

• Registration Number: CTRI/2021/01/030756
• Lead Sponsor: OPD and IPD facilities and Central Library Government Siddha Medical College and Hospital

Brief Summary

The study is a prospective open labelled phase II non-randomized clinical study to evaluate the

therapeutic efficacy of Oorithalthaamarai Chooranam   in the management of  M***adhumegha Noi  muthalavathu avasthai - parutha udal*** (Diabetic Dyslipidemia).

The trial drug wilI be administered at the dose of 30 mg/ kg /BW/Twice a day A/F 90 days

along with water as adjuvant in 60 patients. The trial period of 12 months will be carrying out in

Government Siddha Medical College and Hospital Palayamkottai Tirunelvelli Tamilnadu.  The

primary outcome will be evaluation of therapuetic efficacy of trial drug Oorithalthaamarai Chooranam.

The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of

safety profile of trial drug, assessment of pharmacological and biochemical parameters of  the trial

drug.  In case of any adverse event (AE) is noticed and it will be referred to pharmacovigilance

department of SCRI. Further management of patient will be given in OPD facility.

Detailed Description

Not available

Study Timeline

• Study Completion: 2020-10-29
• Study Start: 2021-01-02
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

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.

• ≤50-60 mg /dl 4.Willing to give blood sample for the investigations.

Exclusion Criteria

• 1.If yes in any one of three a.FBS.
• < 126mg/dl and b.PPBS.
• <140mg/dl and HbA1c < 6.5 2.High lipid profile, dyslipidemia has values of, a.Total cholesterol <199 mg/dl b.LDL <100-130 mg/ dl c.Triglycerides <150-199 mg/dl 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
During treatment or after treatment,	90 days
FBS became 110mg /dl & PPBS160mg/dl and HbA1c 6.5.	90 days
Total cholesterol 199 mg/dl, LDL 159 mg/ dl and Triglycerides 150 mg/dl	90 days

Secondary Outcome Measures

Name	Time	Method
1.Evaluation of safety profile for acute& sub acute toxicity of the trial drug.	2.Evaluation of primary phytochemical analysis in different solvents.

Trial Locations

Locations (1)

Government Siddha Medical College; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government Siddha Medical College

🇮🇳Tirunelveli, TAMIL NADU, India

S HARISH TITTO

Principal investigator

8903660370

harishtitto94@gmail.com