| CTRI Number |
CTRI/2018/09/015775 [Registered on: 20/09/2018] Trial Registered Prospectively |
| Last Modified On: |
27/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of NiKu plus in reducing fever. |
|
Scientific Title of Study
|
A randomised, open label, comparative, parallel group, clinical study to evaluate the anti-pyretic efficacy of JRKs NiKu plus with mild fever of recent 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 |
MMC, Chennai |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU
600 044
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Assistant professor |
| Affiliation |
MMC, Chennai |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU
600 044
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Kannan |
| Designation |
Assistant professor |
| Affiliation |
MMC, Chennai |
| Address |
Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu 600003
Chennai
TAMIL NADU
600 044
India |
| Phone |
7708925866 |
| Fax |
|
| Email |
srkguruvarshan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. JRKs Research and Pharmaceuticals Pvt. Ltd.,
18,19 Perumal Koil Street, Kunrathur,
Chennai - 600 069, INDIA
|
|
|
Primary Sponsor
|
| Name |
Dr JRKs Research and Pharmaceuticals Pvt Ltd |
| Address |
18 & 19 PerumalKoil Street Kunrathur
Chennai - 600 069 INDIA
|
| 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 |
| Dr Ramesh kannan |
PM Medical Centre Hospital |
Room no: 10, Medicine department, P M Medical centre,Wallajapet
Ranipet
Tamil Nadu
Chennai
TAMIL NADU |
7708925866
srkguruvarshan@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B95-B97||Bacterial and viral infectious agents, (2) ICD-10 Condition: B978||Other viral agents as the cause ofdiseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIKU PLUS |
Andrographis paniculata -20%
Zingiber officinale - 10%
Piper nigrum - 10%
Cyperus rotundus - 10%
Tinospora cordifolia - 10%
Adhatoda vasica - 10%
Syzygium cumin - 10%
Momordica Charantia -10%
Excipients: Q.S.
500 mg orally twice daily in the morning and night till fever subsides upto a maximum of 3 days |
| Comparator Agent |
Tab.Paracetamol |
Tab.Calpol 500 mg was used SOS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Proper written informed consent obtained from the patient before any procedure performed.
2.Adults between the age of 18-75 years with an oral temperature of more than 38.0°C (100.4°F)
3.Patient should have not participated in any other clinical trial during the past 3 months.
|
|
| ExclusionCriteria |
| Details |
1.History of allergy to any of the drugs in the study
2.Had taken antipyretics within 8 hours
3.Patient who are unable to consume solid and liquid orals.
4.Renal, hepatic or haematological disorders
5.Bronchial asthma, peptic ulcer disease, vomiting
6.Pregnant or lactating women
7.Patients who are unable to sign informed consent.
8.Patient unwilling or unable to comply with study procedure.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The primary endpoint was defervescence, defined as a core temperature ≤37.1°C (98.7°F).
2.The fever reduction was measured after 30 minutes and 1 hour after drug usage.
3.Decrease in temperature and patients feedback was recorded.
4.The subsequent 2nd and 3rd day the patient was requested to take the drug and provide the feedback.
|
day1,day2,day3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Assessing the efficacy with the pre and post values of clinical assessment (Questionnaire based). |
day1,day2,day3 |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2018 |
| Date of Study Completion (India) |
08/10/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Subjects randomized onto two groups with 24 patients (group 1) and 10 patients (group 2). Group 1 received 1 tablet of NiKu plus orally after food and monitored for 30 minutes and 1 hour. Group 2 received Paracetamol tablets 500mg after food and monitored for 30 minutes and 1 hour. Measurement of body core temperature from the axilla before the consumption of the study drug, and at 0.5 and 1 hour post dose. Patients who responded to NiKu plus were followed up for 3 days and were asked to take the drug, and provide feedback. If fever persists even after the administration of test drug (NiKu plus), tab.Paracetamol was given as rescue medication. |