| CTRI Number |
CTRI/2022/11/047039 [Registered on: 04/11/2022] Trial Registered Prospectively |
| Last Modified On: |
06/01/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To check the bioavailability of Ashwangandha in healthy human volunteers |
|
Scientific Title of Study
|
A Double Blind Balanced Randomized Single Dose Four Treatment Four Sequence Four Period Cross Over Oral Bioavailability Study To Compare Product A Zenroot Ashwagandha 8 % Product B Zenroot Ashwagandha 1.5% Product C KSM-66 Ashwagandha 5% And Product D Sensoril Ashwagandha 10% In Healthy Adult Human Subjects Under Fasting Conditions |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-OA-97 & SLS-CT -0012-22-ASHW Version 01 Date 10 Oct 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Annamalai K MBBS MBA MSc |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Trail Divison
29 A Krishna Madura Vanam Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
annamalai.k@spinoslifescience.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Annamalai K MBBS MBA MSc |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Trail Divison
29 A Krishna Madura Vanam Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
annamalai.k@spinoslifescience.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Annamalai K MBBS MBA MSc |
| Designation |
Principal Investigator |
| Affiliation |
Spinos Lifescience and Research Private Limited |
| Address |
Clinical Trail Divison
29 A Krishna Madura Vanam Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU
641029
India |
| Phone |
|
| Fax |
|
| Email |
annamalai.k@spinoslifescience.com |
|
|
Source of Monetary or Material Support
|
| OmniActive Health Technologies Ltd Thane |
|
|
Primary Sponsor
|
| Name |
Dr Arun Balakrishnan Mr Abhijeet Ashok Morde |
| Address |
Omni Active Health Technologies Ltd New Technology Centre A/10 Road No 1 Wagle Estate Thane |
| Type of Sponsor |
Other [Self] |
|
|
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 Annamalai K |
Spinos Lifescience and Research Pvt Ltd |
Clinical Department
Clinical Trial Division
29 A Krishna Maduravanam
Vellakinar Pirivu
G N Mills Post
Coimbatore
TAMIL NADU |
08637620087
annamalai.k@spinoslifescience.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ehtics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fasting |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
KSM-66 Ashwagandha 5% (600 mg providing 30 mg
total withanolides) |
KSM-66 Ashwagandha Capsules
Oral Dose
4 times (each period once) |
| Intervention |
Not Applicable |
Not Applicable |
| Comparator Agent |
Sensoril Ashwagandha 10% (500 mg providing 50 mg Withanolide glycosides 160 mg of Oligo saccharides |
Sensoril Ashwagandha Capsules
Oral Dose
4 Times (each period once) |
| Comparator Agent |
Zenroot Ashwagandha 1.5% (125 mg providing 1.88
mg total withanolides) |
Zenroot Ashwagandha capsules
Oral Dose
4 times (each period once) |
| Comparator Agent |
Zenroot Ashwagandha 8% (50 mg providing 4 mg total
withanolides) |
Zenroot Ashwagandha Capsules
Oral Dose
4 times (each period once) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Normal, healthy, adult, human subjects (12 Males and 8 Females) of age between 18-55 years (both inclusive) and Body Mass Index (BMI) ranges between 20.00 kg/m2 to 29.99 kg/m2
Subjects who have no evidence of underlying disease during screening and check-in and whose screening is performed within 21 days of check in
Subjects whose screening laboratory values are within normal limits or considered by the physician or principal/clinical investigator to be of no clinical significance
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 system) and vital sign assessments
Generally healthy as documented by 12-lead electrocardiogram (ECG), Chest X-Ray and clinical laboratory assessments |
|
| ExclusionCriteria |
| Details |
Evidence of allergy or known hypersensitivity to Ashwagandha or its metabolites
Subjects with hepatic encephalopathy cholestasis myasthenia pre-existing liver disease alcohol abuse existing tinnitus and pre-existing gallbladder disease
Any major illness in the last three months or any significant ongoing chronic medical illness
Renal or liver impairment
Any disease or condition which might compromise the haemopoeitic, gastrointestinal, renal, hepatic, cardiovascular, musculoskeletal, respiratory, central nervous system, or any other body system, presence of diabetes mellitus and psychosis
History of alcohol addiction or abuse
Consumption of caffeine and /or Xanthine containing products |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the bioavailability of total withanolides from a single oral dose of Product A - Zenroot Ashwagandha 8%, Product B - Zenroot Ashwagandha 1.5%, Product C - KSM-66 shwagandha 5 and Product D - Sensoril Ashwagandha 10% in healthy adult human subjects under fasting conditions |
13 time points
0.00 Hrs
00.25 Hrs
00.50 Hrs
00.75 Hrs
01.00 Hrs
02.00 Hrs
03.00 Hrs
04.00 Hrs
05.00 Hrs
06.00 Hrs
09.00 Hrs
12.00 Hrs
and 24.00 Hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the bioavailability of Withanoside IV, Withanolide A, 12 deoxywithanstramonolide and Withaferin A from a single oral dose of Product A - Zenroot Ashwagandha 8%, Product B - Zenroot Ashwagandha 1.5%, Product C - KSM-66 Ashwagandha 5% and Product D - Sensoril Ashwagandha 10% in healthy adult human subjects under fasting conditions |
13 time points
0.00 Hrs
00.25 Hrs
00.50 Hrs
00.75 Hrs
01.00 Hrs
02.00 Hrs
03.00 Hrs
04.00 Hrs
05.00 Hrs
06.00 Hrs
09.00 Hrs
12.00 Hrs
and 24.00 Hrs |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2022 |
| Date of Study Completion (India) |
13/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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)?
Response - NO
|
|
Brief Summary
|
Demographic data, medical and medication history, physical examination, 12 lead ECG, haematology, biochemistry, serology, urine routine analysis and additionally for females serum pregnancy test, hormone assay (FSH) will be done within 21 days and chest X-ray within 06 months prior to check-in. In each period subjects will be housed in the clinical facility for at least -24.00 hours pre-dose to 24.00 hours post-dose and the washout period of at least 05 days from the successive dosing day. During the entire in-house stay from -24.00 hrs prior to dosing till 24.00 hrs post-dose, subjects will be served dinner on the day of check-in of each period. Standard diet will be served at around -23.00, -20.00, -16.00, -12.00 hrs pre-dose. Thereafter, subjects will be fasted for at least 10.00 hours prior to dosing and standard diet will be served at 04.00, 08.00 and 12.00 hours post-dose, in each period. All meal plans will be identical in all the periods of the study. Subjects will be selected on the basis of abstinence from any prescription medications within 14 days prior to study check in and they will be instructed not to take any prescription medications throughout the study. Subjects will be instructed not to take any over the counter medicinal products, herbal medications throughout the study and they will be selected on the basis of abstinence from over the counter medicinal products, herbal medications including Ashwagandha 07 days prior to check-in of period-I till end of the study.
|