A clinical trial to study the effect of Siddha drug Thiripalai mathirai in Pitha Paandu (Iron deficiency anaemia)

Phase 2

Not yet recruiting

• Conditions: Pitha Paandu Iron Deficiency Anaemia

• Registration Number: CTRI/2018/04/013122
• Lead Sponsor: Dr S Neelavathi MD Siddha PhD

Brief Summary

The study is A Prospective Open Labelled Non Randomized Phase 2 Clinical trial to evaluate the therapeutic efficacy of THIRIPALAI MATHIRAI 1 with the adjuvant KARISALAI KUDINEER 100ml BD for 30 days in 40 patients during the trial period of 20 months that will be conducted in Govt Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India

The primary outcome will be the therapeutic efficacy of  trial medicine Thiripalai Mathirai with the adjuvant Karisalai kudineer

The secondary outcome will be the evaluation of siddha diagnostic parameters Safety of trial drug and the adjuvant Pharmacological and Biochemical analysis of trial drug and the adjuvant

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-16
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

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

Inclusion Criteria

Patients with Hb level between 7 to 10 grams Pallor of skin mucous membrane conjunctiva nailbeds Fatigue Shortness of breath Palpitation Anorexia Worm infestations Blood loss due to Menstrual disorders Hemorrhoids Peptic ulcer Smear showing hypochromic microcytic RBCs.

Exclusion Criteria

Patients with Congenital heart disease Chronic renal disease Liver disease Inherited haemolytic defects Thalessemia Thyroid disorder Diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical and Therapeutic efficacy of the siddha medicine Thiripalai Mathirai in Pitha Paandu	30 days

Secondary Outcome Measures

Name	Time	Method
Evaluation of siddha diagnostic parameters	Safety of trial drug and the adjuvant

Trial Locations

Locations (1)

Govt Siddha Medical College and Hospital Palayamkottai; 🇮🇳 Tirunelveli, TAMIL NADU, India

Govt Siddha Medical College and Hospital Palayamkottai

🇮🇳Tirunelveli, TAMIL NADU, India

Maheshwari B

Principal investigator

7639854840

maggi.b1992@gmail.com