Effect of ayurvedic drug in viral fever

Phase 3

Completed

• Conditions: Health Condition 1: B338- Other specified viral diseases

• Registration Number: CTRI/2019/02/017565
• Lead Sponsor: Apex Laboratories Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-04-30
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 48

Inclusion Criteria

1.Proper written informed consent obtained from the patient before

any procedure performed.

2. Males and females between the age of 18-75 years with an oral

temperature of more than 38.0°C (100.4°F). with or without

associated rash, body pain and joint pain, severe headache especially

behind the eyes, nausea and vomiting.

3. Patients having Viral fever with thrombocytopenia, with a platelet count between 80,000 /micro litre to100,000/micro litre.

4. Subjects with stable vitals like pulse and blood pressure

5. Patient should have not participated in any other clinical trial during

the past 3 months.

Exclusion Criteria

1. Patients with Dengue hemorrhagic fever grade III and IV

2. Patients with platelet count less than 80,000/micro litre.

3. Pregnant or lactating women

4. Patients who have received blood or blood products transfusion

during the current illness

5. Patients with thrombocytopenia Purpura (ITP), Leukemia,

Hemophilia

6. Patients who have a serum ALT level 3 times higher than the

upper limit of the normal range ( >165 U/L),

7. Impaired renal function with serum creatinine > 1.5 mg/dl (males)

and > 1.4 mg/dl (females),

8. Hypersensitivity to any of the components of the formulation,

9. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this

clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of efficacy parameters namely platelet count, haematocrit, prothrombin time, bleeding time, clotting time â?? baseline & on each day from day 1 to day 3 and on days 5 & 7 (For 24 subjects who suffer from viral fever with thrombocytopenia) <br/ ><br>Assessment of clinical parameters namely temperature, fever score, arthralgia, myalgia, headache and loss of appetite - baseline and on days 2,4 & 7. (For all 48 subjects)Timepoint: Day 1 to 7

Secondary Outcome Measures

Name	Time	Method
To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaireTimepoint: day 1 to 7