Comparative study to evaluate the Effectiveness of GanjhuVirTM a herbal antiviral in Cases of Dengue Fever with Thrombocytopenia

Phase 2/3

Completed

Conditions: Other specified viral diseases,

Registration Number: CTRI/2019/01/017096

Lead Sponsor: Radhika Ayurveda Research and Development

Brief Summary: It is an open labeled, randomized,comparative study to evaluate the Effectivenessof GanjhuVirTM a herbal antiviral in Cases of Dengue Fever withThrombocytopenia. he study will be conducted asper computer generated randomization list, subject will either be randomized todrug group or control group in 1:1ratio. Subjects will be advised to take given medication in a dose of 5 mlthrice daily orally after meals with water for 05 days. The primary objectivesof the study will be to assess change in mean platelet count. The secondaryobjectives will be to assess for overall improvement, percentage ofparticipants with adverse events, vitals, tolerability of study drugs andchanges in myalgia recovery from baseline to 5 days

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.Male or Female Subject aged between 18 and 60 years 2.Diagnosis confirmed as DF Grade 1.
3.Platelet count is below 100,000 and above 30,000 per ÂµL 4.ALT/SGPT level less than 165 U/L 5.Subject willingly giving written informed consent.

Exclusion Criteria

1.Patient diagnosed with DHF Grade 3 or 4 2.Platelet levels are less than 30,000 per ÂµL 3.Patient is either pregnant or lactating 4.Has received blood products or blood transfusion during the current hospital stay Or during last one month 5.Is the patient diagnosed with ITP, Leukaemia or Hemophilia 6.Serum Creatinine is more than 1.4 mg/dl (if female) or 1.5mg/dl (if male) 7.Patient has participated in another trial within past one month 8.Patient with positive HIV infection 9.The investigator can exclude patient at his/her discretion depending upon the condition of the patient.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in mean platelet count	Screening visit, Visit 1 Day1,Visit 2 Day3, Visit 3 Day5

Secondary Outcome Measures

Name	Time	Method
Change in global assessment for overall improvement	Percentage of participants with adverse events

Trial Locations

Locations (1): Lokmanya Medical Research Center
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Medical Research Center
🇮🇳Pune, MAHARASHTRA, India
Ms Varsha Bachkar
Principal investigator
8446623333
research.lmrc@gmail.com