A Clinical study on Alli Choornam in management of Kapha Neerizhivu noi(Diabetic Peripheral Neuropathy)

Phase 2

Not yet recruiting

• Conditions: Type 2 diabetes mellitus with neurological complications,

• Registration Number: CTRI/2020/02/023625
• Lead Sponsor: Government Siddha Medical College and Hospital

Brief Summary

The study is a prospective open labelled phase II non-randomised clinical trial to evaluate the efficacy of Alli Chooranam in the management of Kapha Neerizhivu(Diabetic peripheral neuropathy).The trial drug will be administered at the dose of 72mg/Kg/BW/Twice a day After food for 90 days with luke warm water as adjuvant in 60 patients.The trial period of 12 months will be carrying out in Government Siddha Medical College and Hospital Playamkottai Tirunelveli Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug Alli Chooranam. The secondary outcome will be the evaluation of Siddha diagnostic parameters,assessment of safety profile of trial drug,assessment of pharmacological and biochemical actions of the trial drug.In case of any adverse event (AE) is noticed it will be referred to pharmacovigilance department of SCRI. Furthur management of the patient will be given in OPD facility.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-04-12
• Study Start: 2020-02-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Previously diagnosed Type II Diabetes patients having Fasting blood sugar more than 110 mg/dl Postprandial more than 140 mg/dl Random blood sugar 180 mg/dl HbA1C more than 7 with peripheral neuropathy(Sensory).

Exclusion Criteria

Type I Diabetes mellitus Diabetes Insipidus Gestational Diabetes mellitus Chronic Kidney diseases having S Creatinine more than 2 mg/dl Motor neuron disease Presence of foot ulcer Myopathy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
During treatment or after treatment reduction of following symptoms	90 days
HbA1C below 6mg/dl	90 days
Reduction in numbness in the limbs	90 days
Glucose level within normal limit	90 days
reduction in general tiredness,malaise.	90 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of physicochemical,phytochemical,pharmacological activities of Alli Chooranam.	Evaluation of Siddha parameters (including Envagai thervu) in Kapha Neerizhivu during trial period.

Trial Locations

Locations (1)

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

Government Siddha Medical College

🇮🇳Tirunelveli, TAMIL NADU, India

Janani Syamaroopa Jnanthapaswini

Principal investigator

9447709745

jsrjtp@gmail.com