| CTRI Number |
CTRI/2019/02/017565 [Registered on: 08/02/2019] Trial Registered Prospectively |
| Last Modified On: |
25/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of ayurvedic drug in viral fever |
|
Scientific Title of Study
|
A RANDOMIZED, OPEN LABEL, PARALLEL GROUP CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CLEVIRA IN FEVER OF VIRAL ORIGIN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Kannan |
| Designation |
Assistant Professor |
| Affiliation |
Madras Medical College |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Chennai
TAMIL NADU
Dr Ramesh kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Assistant Professor |
| Affiliation |
Madras Medical College |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Chennai
TAMIL NADU
Dr Ramesh kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Assistant Professor |
| Affiliation |
Madras Medical College |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Room no:10, Medicine OPD, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu.
Chennai
TAMIL NADU
Dr Ramesh kannan
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Apex Laboratories Pvt. Ltd. Chennai. |
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
III Floor, SIDCO Garment Complex, Guindy, Chennai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 |
| DrVanitha R Muralikumar |
Sri Sairam Ayurveda Medical College & research centre |
Sai Leo Nagar, Poonthandalam, West Tambaram, Chennai, 600044
Chennai
TAMIL NADU |
9176677750
drvmkmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ki3 |
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
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not Applicable |
| Intervention |
tablet Clevira 100 mg. |
one tablet twice daily for one week.
Composition:
Erandakarkati (Carica papaya)-Lf. – 100mg
Mahanimba (Melia azedarach)-Lf. – 100mg
Kalmegh (Andrographis paniculata)-Herb – 100mg
Usira (Vettivera zizanoides)-Rt.– 35mg
Patola (Tricosanthus dioica)-Wh.Pl.– 35mg
Musta (Cyperus rotundus)-Rz. – 35mg
Sunthi (Zingiber officinale)- Rz. – 35mg
Maricha (Piper nigrum)-Fr. – 35mg
Grismachatraka (Mollugo cerviana)-Wh.Pl.– 35mg
Guduchi (Tinospora cordifolia)-St. – 10mg
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of efficacy parameters namely platelet count, haematocrit, prothrombin time, bleeding time, clotting time – 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)
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) |
Day 1 to 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor for any adverse events during the study period and assess the quality of life using a pre-and post-feedback questionnaire |
day 1 to 7 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
11/02/2019 |
| Date of Study Completion (India) |
30/04/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
|
Participants will be randomized into 4
groups with 12 patients in each group.
·
Group
1 – Patients diagnosed as viral fever with thrombocytopenia will receive
treatment as per the Ayurvedhic
physician advice .
·
Group
2 - Patients diagnosed as viral fever
with thrombocytopenia will receive treatment as per the Ayurvedhic physician advice. In addition
tablet CLEVIRA will be given twice daily for 7 days.
·
Group
3 – Patients diagnosed as viral fever other than fever with thrombocytopenia
will receive treatment as per the Ayurvedhic physician advice .
·
Group
4 - Patients diagnosed as viral fever other than fever with thrombocytopenia
will receive treatment as per the Ayurvedhic physician advice. In addition
tablet CLEVIRA will be given twice daily for 7 days.
|
Assessment of
efficacy parameters namely platelet count, haematocrit, prothrombin time,
bleeding time, clotting time – 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).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). Adverse events and quality of life will be monitored throughout the study period.
|
|
|