| CTRI Number |
CTRI/2019/01/017096 [Registered on: 15/01/2019] Trial Registered Prospectively |
| Last Modified On: |
28/06/2019 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study to evaluate the Effectiveness of GanjhuVirTM a herbal antiviral in Cases of Dengue Fever with Thrombocytopenia |
|
Scientific Title of Study
|
An open labeled, randomized, comparative study to evaluate the Effectiveness of GanjhuVirTM a herbal antiviral in Cases of Dengue Fever with Thrombocytopenia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| RARD-GV13 version 1.0 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sharad Dhawade |
| Designation |
Coordinator Dept of Ayurved, 4 th floor, lokmanya medical research centre |
| Affiliation |
Department Coordinator Lokmanya medical resaerch centre |
| Address |
Lokmanya Medical Resaerch Centre, Lokmanya Hospital, Chinchwad, Pune 33
Pune
MAHARASHTRA
411033
India |
| Phone |
|
| Fax |
|
| Email |
drsdhawade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sharad Dhawade |
| Designation |
Coordinator Dept of Ayurved, 4 th floor |
| Affiliation |
Lokmanya medical research centre |
| Address |
lokmanya medical research centre.
Chinchwad, Pune
Pune
MAHARASHTRA
411033
India |
| Phone |
|
| Fax |
|
| Email |
drsdhawade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Ganjhu |
| Designation |
Head Research and development |
| Affiliation |
Radhika Ayurveda Research and Development |
| Address |
Radhika Ayurveda Research and Development
Bhalekar Nagar, Pimple Gurav, Pune, Maharashtra 411027
Pune
MAHARASHTRA
411027
India |
| Phone |
|
| Fax |
|
| Email |
research.rard@gmail.com |
|
|
Source of Monetary or Material Support
|
| Radhika Ayurveda Research and Development |
|
|
Primary Sponsor
|
| Name |
Radhika Ayurveda Research and Development |
| Address |
Bhalekar Nagar, Pimple Gurav, Pune, Maharashtra 411027 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Varsha Bachkar |
Lokmanya Medical Research Center |
Department of Ayurved
4th Floor
Railway station road Near Chnchwad Station Chinchwad Pune 33
Pune
MAHARASHTRA |
8446623333
research.lmrc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokmanya Medical Research Center Ethics Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B338||Other specified viral diseases, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Ganjhuvir Liquid |
It contains extract of Desmodium gangeticum root. 10 ml twice a day |
| Comparator Agent |
Standard Management
|
Standard Management of dengue like analgesics, antipyretics and iv fluid replenishment for 5 days as required |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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 µL
4.ALT/SGPT level less than 165 U/L
5.Subject willingly giving written informed consent
|
|
| ExclusionCriteria |
| Details |
1.Patient diagnosed with DHF Grade 3 or 4
2.Platelet levels are less than 30,000 per µL
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in mean platelet count |
Screening visit, Visit 1 Day1,Visit 2 Day3, Visit 3 Day5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in global assessment for overall improvement
Percentage of participants with adverse events
Changes in the vitals, Tolerability of study
drugs, myalgia etc. |
Screening visit, Visit 1 Day1,Visit 2 Day3, Visit 3 Day5 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/01/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is an open labeled, randomized,
comparative study to evaluate the Effectiveness
of GanjhuVirTM a herbal antiviral in Cases of Dengue Fever with
Thrombocytopenia. he study will be conducted as
per computer generated randomization list, subject will either be randomized to
drug group or control group in 1:1
ratio. Subjects will be advised to take given medication in a dose of 5 ml
thrice daily orally after meals with water for 05 days. The primary objectives
of the study will be to assess change in mean platelet count. The secondary
objectives will be to assess for overall improvement, percentage of
participants with adverse events, vitals, tolerability of study drugs and
changes in myalgia recovery from baseline to 5 days
|