| CTRI Number |
CTRI/2017/11/010680 [Registered on: 28/11/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/11/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A trial to test the safety of a drug. |
|
Scientific Title of Study
|
Phase 1 clinical trial for assessment of safety of a multi component botanical therapeutic SKBSITA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ashok Kumar |
| Designation |
Chairman |
| Affiliation |
SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs) |
| Address |
Drug discovery Division,
15, Prayag Sarover,
Ramghat Road
Aligarh
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8126688922 |
| Fax |
|
| Email |
ashok846@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashok Kumar |
| Designation |
Chairman |
| Affiliation |
SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs) |
| Address |
Drug discovery Division,
15, Prayag Sarover,
Ramghat Road
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8126688922 |
| Fax |
|
| Email |
ashok846@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashok Kumar |
| Designation |
Chairman |
| Affiliation |
SK Biotherapeutics Pvt. Ltd. (Previously SK Biolabs) |
| Address |
Drug discovery Division,
15, Prayag Sarover,
Ramghat Road
Aligarh
UTTAR PRADESH
202001
India |
| Phone |
8126688922 |
| Fax |
|
| Email |
ashok846@gmail.com |
|
|
Source of Monetary or Material Support
|
| SK Biolabs
15, Prayag Sarover,
Ramghat Road
Aligarh-202001 (U.P.)
India |
|
|
Primary Sponsor
|
| Name |
SK Biolabs |
| Address |
15, Prayag Sarover,
Ramghat Road,
Aligarh-202001 (U.P.)
India |
| Type of Sponsor |
Research institution |
|
|
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 |
| Ashok Kumar |
SK Biolabs |
Drug Discovery Division,
15, Prayag Sarover,
Ramghat Road
Aligarh-202001
Aligarh
UTTAR PRADESH |
8126688922
ashok846@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SK Biolabs Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No comparator agent |
Not applicable |
| Intervention |
SKBSITA |
Dose: Two 500 Mgs capsules (equivalent to 5 Gms whole powder);
Frequency: Every three-four hours;
Route of administration: Oral;
Duration of therapy: Minimum 15 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Healthy Human Volunteers |
|
| ExclusionCriteria |
| Details |
Patients suffering from any disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Any toxic side effects after oral administration of SKBSITA such as fever, nausea, vomiting, cramps, headache, stomachache, backache, palpitations, dizziness, paralysis,skin rashes, choking, numbness, anxiety, depression, cough, shortness of breath etc. |
4 Hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any toxic side effects after oral administration of SKBSITA such as fever, nausea, vomiting, cramps, headache, stomachache, backache, palpitations, dizziness, paralysis,skin rashes, choking, numbness, anxiety, depression, cough, shortness of breath etc. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
02/09/2002 |
| Date of Study Completion (India) |
04/03/2003 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
No Publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Multi component botanical therapeutic SKBSITA causes no toxicity in healthy human volunteers. |