A clinical study to study the drug Seenthil Sarkkarai on Neerizhivu

Phase 2

Recruiting

• Conditions: Iya Neerizhivu

• Registration Number: CTRI/2018/01/011497
• Lead Sponsor: Dr S Neelavathi

Brief Summary

The Study is prospective open labelled randomized phase II clinical trial to evaluate the therapeutic efficacy of herbal formulation of seenthil sarkkarai for the treatment of IYA NEERIZHIVU 130mg kg BW daily three time per day with ghee for 90 days in 40 patients during the trial period of 12 months that will be conducted in government siddha medical college and hospital palayamkottai tirunelveli tamilnadu the primary out come will be the therpeutic eficacy of trial drug Seenthil Sakkarai on IYA NEERIZHIVU The Secondary outcome will be the evaluation of Siddha diagnositc parameters

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-04
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Type 2 diabetes mellitus If yes in any of three FBS above 110 mg per dl and below and equal 250mg per dl or PPBS above 160 mg per dl and below and equal 350mg per dl HbA1c above 6.4 and below 10 Persistent cases of COPD as per the standard key indicators for assessment FEV1 between above 50 percentage and below 80 percentage of the predicted value Willing to give blood sample for the investigations Patients who are mono therapy alone.

Exclusion Criteria

Age below 40 and above 70 Type 1 diabetes mellitus If yes in any of three FBS below 109 mg per dl and above and equal 251 mg per dl or PPBS below 159 mg per dl and above and equal 351 mg per dl HbA1c below 6.3 and above 10.1 FEV1 below 50 percentage and above 80 percentage of the predicted value Pregnant woman and plan to pregnant six months Lactating mother Chronic kidney disease or Renal failure Corticosteroid therapy Chronic active hepatitis or cirrhosis or ascites Multisystem involvement.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The therapeutic efficacy of trial drug Seenthil Sarkkarai on IYA NEERIZHIVU	90 days

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

Sarangapany Uthayanan

Principal investigator

9894468602

dr.uthayanan@gmail.com