| CTRI Number |
CTRI/2017/12/010788 [Registered on: 06/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
05/12/2017 |
| 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 (SKBDEVI) in healthy human volunteers |
| 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 |
SKBDEVI |
Dose: 500 mgs capsule
Frequency:Every 3-4 hours
Route of administration: Oral
Duration of therapy: 3-4 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 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 intake of SKBDEVI such as fever, nausea, vomiting, headache, depression, irritation, anxiety, palpitation, choking, fainting, cough, skin rashes etc. |
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any toxic side effects after oral intake of SKBDEVI such as fever, nausea, vomiting, headache, depression, irritation, anxiety, palpitation, choking, fainting, cough, skin rashes etc. |
4 weeks |
|
|
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)
|
01/02/1999 |
| Date of Study Completion (India) |
02/08/1999 |
| 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)
|
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 SKBDEVI causes no toxicity in healthy human volunteers except some volunteers reported mild constipation after 4 weeks. |