A Prospective Open Labelled non randomized phase II Clinical trial on Alli Choornam in management of Kapha Neerizhivu noi(Diabetic Peripheral Neuropathy)
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- During treatment or after treatment reduction of following symptoms
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 36.00 Year(s) to 68.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
During treatment or after treatment reduction of following symptoms
Time Frame: 90 days
HbA1C below 6mg/dl
Time Frame: 90 days
Reduction in numbness in the limbs
Time Frame: 90 days
Glucose level within normal limit
Time Frame: 90 days
reduction in general tiredness,malaise.
Time Frame: 90 days
Secondary Outcomes
- Evaluation of physicochemical,phytochemical,pharmacological activities of Alli Chooranam.(Evaluation of Siddha parameters (including Envagai thervu) in Kapha Neerizhivu during trial period.)