A clinical study to study the drug kadukkai chooranam on Neerizhivu

Phase 2

Not yet recruiting

• Conditions: Akkini Selathumam

• Registration Number: CTRI/2018/03/012756
• Lead Sponsor: Dr S Neelavathy

Brief Summary

The Study is  a prospective open labelled phase II non randomized clinical trial to evaluate the therapeutic efficacy of herbal formulation of kadukkai chooranam for the treatment of AKKINI SELATHUMAM 25mg kg BW daily two time per day  with warm water for 90 days in 40 patients during the trial period of 18 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic efficacy of trial drug  kadukkai chooranam on akkini selathumam the secondary outcome will be evaluation of siddha diagnostic parameters

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2018-03-21
• Study Start: 2018-03-30

Recruitment & Eligibility

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

Inclusion Criteria

Type II diabetes mellitus Previously diagnosed patients which are uncontrolled or poorly controlled for more than 5 years duration of the illness If yes in any of three FBS above 126 mg per dl and below and equal 250mg per dl or PPBS above 200 mg per dl and below and equal 350mg per dl HbA1c above 6.5 and below 12 Patients with diabetic neuritis complains such as pain numbness tingling sensation of the lower limb Neuropathic pain scale is less than 4 by 10 The clinical diagnosis was confirmed by of nerve condution studies.

Exclusion Criteria

B12 deficiency Severe anaemia Smoking or alcohol neuropathy Presence of foot ulcer Endocrine disorder Myopathy Systemic hypertension Angina and heart failure Type I diabetes mellitus Pregnancy Lactating mother Chronic kidney disease or renal failure Chronic liver disease Femoral nerve dysfunction Mechanical and traumatic nerve injury.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The therapeutic efficacy of trial drug kadukkai chooranam on AKKINI SELATHUMAM	The therapeutic efficacy of trial drug kadukkai chooranam on AKKINI SELATHUMAM

Secondary Outcome Measures

Name	Time	Method
Evaluation of Siddha diagnostic parameters	90 days

Trial Locations

Locations (1)

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

Government Siddha Medical College

🇮🇳Tirunelveli, TAMIL NADU, India

Dr Rajendram Ajanthan

Principal investigator

8220898656

raajanth04@gmail.com