| CTRI Number |
CTRI/2017/02/007959 [Registered on: 27/02/2017] Trial Registered Prospectively |
| Last Modified On: |
25/02/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To evaluate the safety of treatment of SNS-01/16 in healthy adult human female volunteers in fasting conditions. |
|
Scientific Title of Study
|
A Randomized, Open Labeled, Placebo Controlled, Two-Arm, Parallel Group, Multi-Centric, Oral Clinical Study To Evaluate The Sns-01/16 In Healthy Adult Human Female Volunteers Under Fasting Conditions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr P Nagarajan |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life Sceience and Research Pvt Ltd |
| Address |
Spinos Life Science and Research Private Limited,
Clinical department
No.29 A, “Krishna Madhuravanamâ€,
Vellakinar Pirivu, Thudiyalur, Coimbatore-641029.
Tamil Nadu, India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
9884457106 |
| Fax |
|
| Email |
info@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Nagarajan |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life Sceience and Research Pvt Ltd |
| Address |
Spinos Life Science and Research Private Limited,
Clinical department
No.29 A, “Krishna Madhuravanamâ€,
Vellakinar Pirivu, Thudiyalur, Coimbatore-641029.
Tamil Nadu, India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
9884457106 |
| Fax |
|
| Email |
info@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr P Nagarajan |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Life Sceience and Research Pvt Ltd |
| Address |
Spinos Life Science and Research Private Limited,
Clinical department
No.29 A, “Krishna Madhuravanamâ€,
Vellakinar Pirivu, Thudiyalur, Coimbatore-641029.
Tamil Nadu, India
Coimbatore
TAMIL NADU
641029
India |
| Phone |
9884457106 |
| Fax |
|
| Email |
info@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| Cholayil Pvt Ltd
No 8 J Block 6th Avenue
Anna Nagar (East)
Chennai 600 102
Tamil Nadu India. |
|
|
Primary Sponsor
|
| Name |
Cholayil Pvt Ltd |
| Address |
No 8 J Block 6th Avenue
Anna Nagar East
Chennai 600 102
Tamil Nadu India |
| Type of Sponsor |
Other [Ayurvetha formulations] |
|
|
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 P Nagarajan B A M S |
SpinoS Life Science and Research Pvt Ltd |
Clinical Department
Clinical trails division
Door No 29 A Krishna Madhuravanam
Vellakinar Pirivu Thudiyalur Coimbatore 641029
Tamil Nadu India
Coimbatore
TAMIL NADU |
9884457106
info@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Ramana Maharishi Rangammal Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy adult human female volunteers under fasting conditions |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Normal, healthy, adult, female human subjects of age between 18-65 years with a Body Mass Index (BMI) ranges between 18.5 kg/m2 to 29.9 kg/m2
2. Ability to provide written informed consent prior to participation in the study.
3. Subjects who have no evidence of underlying disease during screening and day 01 dosing and whose screening is performed within 07 days of day 01 dosing .
4. Subjects whose screening laboratory values are within normal limits or considered by the physician or investigator to be of no clinical significance.
5. Healthy as documented by the medical history, physical examination (including but may not be limited to an evaluation of the cardiovascular, gastrointestinal, respiratory, musculoskeletal and central nervous systems) and vital sign assessments.
6. Generally healthy as documented by 12-lead electrocardiogram (ECG), X-Ray and clinical laboratory assessments.
7. Non- smokers or ex-smokers. Ex-smokers are defined as someone who has completely stopped smoking for at least the past 03 months.
8. Willing to comply to all requirements of this study protocol as well as instructed by the study personnel
9. Subjects within normal limits or clinically non-significant laboratory evaluation results for FSH & LH. |
|
| ExclusionCriteria |
| Details |
1. History of allergy or hypersensitivity reactions to SNS-01/16 or any related compound at any dose.
2. Subjects with hepatic encephalopathy, cholestasis, myasthenia, pre-existing liver disease, alcohol abuse, existing tinnitus, renal or liver impairment and pre-existing gallbladder disease.
3. Any major illness in the last three months or any significant ongoing chronic medical illness.
4. Renal or liver impairment.
5. Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, Musculoskeletal, respiratory, central nervous system, diabetes, psychosis or any other body system.
6. History of alcohol addiction or abuse.
7. History of difficulty in swallowing.
8. Any blood donation / excess blood loss within 90 days of check-in.
9. Ingestion of any hormonal agent at any time within 14 days prior to start of dosing.
10. Subjects demonstrating a positive pregnancy screen.
11. Subjects whose menstruation cycle coincides with the study periods
12. Subjects who are currently lactating.
13. Subjects likely to become pregnant during conducting of the study
14. Use of hormone replacement therapy for a Period of 06 months prior to dosing. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| monitor safety and tolerability |
Visit 02, 03, 04, 05 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to monitor body weight and Hair loss percentage |
Visit 01, 02, 03, 04 and 05 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/02/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
yet to be publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To evaluate the tolerability, safety and compliance of treatment of SNS-01/16 in 20 randomized, open labeled, placebo controlled, two-arm, parallel group, healthy adult human female volunteers under fasting conditions. total study duration is 100 days |