A clinical trial on SARAKKONDRAI ILAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V (DIABETES MELLITUS AND ITS COMPLICATIONS)

Phase 2

Not yet recruiting

• Conditions: Endocrine, nutritional and metabolic diseases,

• Registration Number: CTRI/2022/02/040177
• Lead Sponsor: Government Siddha Medical College and Hospital

Brief Summary

The study is a Prospective open labelled non randomized phase II clinical trial on SARAKKONDRAI ILAI CHOORANAM in the management of MADHUMEGA AVATHAIGAL I-V (DIABETES MELLITUS AND ITS COMPLICATIONS).The trial drug will be administered at the dose of 1250-1500 mg Twice a day orally A/F for 90 days along with hot water adjuvant in 40 patients.The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli.The primary outcome will be evaluation of therapeutic efficacy of trial drug SARAKKONDRAI ILAI CHOORANAM.The secondary outcome will be evaluation of siddha parameters, assessment of safety profile of trial drug, assessment of Pharmacological and biochemical parameters of trial drug.In case any adverse event (AE) is noticed and it will be referred to pharmacovigilance department of SCRI.Further management of patients wil be given in OPD facility.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-09-02
• Study Start: 2022-12-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.TypeII diabetes mellitus, previously diagnosed diabetic patients which are uncontrolled or poorly controlled for more than 2 years duration of the illness.2.Patients with symptoms of Polyuria, Polydipsia, Polyphagia, nocturia, numbness, tingling sensation.3.Patient willing to give blood and urine sample before and after the treatment.

Exclusion Criteria

• 1.Age below 34 years and above 60years.2.TypeI diabetes mellitus 3.Gestational DM 4.Diabetes inisipidus 5.Pregnancy 6.Lactating mother 7.
• Chronic kidney disease 8.
• Chronic Liver disease 9.Ischemic heart disease 10.
• Other types of neuropathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
If during treatment or after treatment 1.FBS became less than 126 mg/dl and PPBS less than 200 mg/dl and HbA1C less than 6.5 2.Reduction of the signs and symptoms of i.e.Polyuria, Polydypsia, Polyphagia, nocturia, numbness, tingling sensation,nausea.3.Achieving of optimal BMI 4.Achieving of optimal blood pressure (supine and erect positions)	90 days

Secondary Outcome Measures

Name	Time	Method
1.To evaluate the biochemical physico-chemical and phyto chemical analysis of clinical trial drug	2.To evaluate the antimicrobial activity of trial drug

Trial Locations

Locations (1)

Government siddha Medical College and Hospital; 🇮🇳 Tirunelveli, TAMIL NADU, India

Government siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

DrPraise Prabha

Principal investigator

9481846922

prabhapraise@gmail.com