A clinical study on Karisalai mathirai for Pitha paandu (Iron deficiency Anaemia)

Phase 2

Not yet recruiting

• Conditions: Iron deficiency anemia, unspecified,

• Registration Number: CTRI/2019/05/019214
• Lead Sponsor: Govt Siddha Medical College and Hospital

Brief Summary

The study is a prospective open labelled ,non- randomized , phase II clinical study to evaluate the therapeutic efficacy of KARISALAI MATHIRAI in the management of Pitha Paandu(iron deficiency aneamia). The trial drug will be administered at the dose of 1-2 tablets BD A/F along with Butter milk for 45 days in 60 patients . The trial period of 12 months will be carrying out in Govt Siddha Medical College and Hospital,  Palayamkottai , Tirunelveli ,Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug KARISALAI MATHIRAI. The secondary outcome will be evaluation of Siddha diagnostic parameters , assessment of safety profile, pharmacological and biochemical parameters of trial drug.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2019-05-16
• Study Start: 2019-05-21

Recruitment & Eligibility

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

Inclusion Criteria

• 1.Hb level between 7.1.
• 10 grams 2. Pallor of skin , mucous membrane, conjuctiva, nailbeds 3. Fatigue, shortness of breath, palpitation 4. Anorexia 5.Blood loss due to menstrual disorders,hemorrhoids and peptic ulcer.

Exclusion Criteria

• Congenital heart disease 2.
• Patients with chronic renal disease 3.
• Liver disease 4.Inherited hemolytic defects 5.Thalassemia 6.
• Thyroid disease 7.Diabetes mellitus.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Relief of clinical symptoms mentioned in inclusion criteria	45 days
2. Increase in HB level	45 days
3. Improvement in lab parameters	45 days

Secondary Outcome Measures

Name	Time	Method
1. Evaluation of heamatinic activity of trial drug	2. Evaluation of additional effects and changes of siddha parameters in Pitha Paandu

Trial Locations

Locations (1)

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

Govt Siddha Medical College and Hospital

🇮🇳Tirunelveli, TAMIL NADU, India

A KARTHICK

Principal investigator

9042516331

draskarthick@gmail.com