| CTRI Number |
CTRI/2020/10/028397 [Registered on: 13/10/2020] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
BA/BE |
|
Type of Study
|
|
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
To study the bioavailability and bioequivalence of four Ashwagandha extracts in healthy adults |
|
Scientific Title of Study
|
A balanced, randomized, double-blind, four-treatment, four-period, four-sequence, single-dose, four-way crossover bioavailability study of four different formulations of Ashwagandha (Withania somnifera) in healthy, adult, human subjects under fasting condition |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AN-08-SHO1119H2-ARD05, Version 02 dated 14 Sep 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Deputy General Manager, Research and Development |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
04842622612 |
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Deputy General Manager, Research and Development |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09447818432 |
| Fax |
04842622612 |
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Giby Abraham |
| Designation |
Research Associate |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Division of Research and Development, Clinical Trial Department, No.7/8, Bank Road, Aluva
Ernakulam
KERALA
683101
India |
| Phone |
09288004381 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Private Limited, Bank Road, Aluva, Kerala, India - 683 101 |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Private Limited |
| Address |
Bank Road, Aluva, Kerala, India - 683 101 |
| Type of Sponsor |
Other [Neutraceutical Company] |
|
|
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 Priyank Rathi |
Synergen Bio Private Limited |
Unit Nos. 101 to 104, Sai Chambers,
302, Old Mumbai-Pune Highway,
Wakadewadi, Shivajinagar, Pune-411003
Pune
MAHARASHTRA |
91-20-25540555
91-20-25540444
drpriyank.rathi@synergenbio.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sai Sneh Hospital (IECSSH) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bioavailability and bioequivalence of four Ashwagandha extracts |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ashwagandha extract (A) |
Single day, Oral administration of Single dose of 480mg containing 185mg total withanolides |
| Comparator Agent |
Ashwagandha extract (B) |
Single day, Oral administration of Single dose of 1800mg containing 185mg total withanolides |
| Comparator Agent |
Ashwagandha extract (C) |
Single day, Oral administration of Single dose of 3700mg containing 185mg total withanolides |
| Comparator Agent |
Ashwagandha extract (D) |
Single day, Oral administration of Single dose of 7400mg containing 185mg total withanolides |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy, human subjects (Male and/or non-pregnant, non-lactating female) aged between 18 and 45 years (inclusive of both).
2. Female of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 21 days prior to initiation of the study. Female subject must have a negative urine pregnancy test prior to check-in of each period. They must be using an acceptable form of contraception.
3. For female of childbearing potential, acceptable forms of contraception include the following:
i.Non hormonal intrauterine device in place for at least 3 months prior to the start of the study and remaining in place during the study period and for 07 days following last dose of the study medication, or
ii.Barrier methods containing or used in conjunction with a spermicidal agent, or
iii.Surgical sterilization or
iv.Practicing sexual abstinence throughout the course of the study.
4. Female will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
i.Postmenopausal with spontaneous amenorrhea for at least one year, or
ii.Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
iii.Total hysterectomy and an absence of bleeding for at least 3 months.
5. Male agreeing to use appropriate contraceptive measures like Double Barrier method (Condom), and should not donate sperm etc. during study and 07 days after completion of study.
6. Subjects with a BMI between 18.50-30.00 kg/m2 (inclusive of both) and body mass not less than 50.00 kg.
7. Subjects in normal health as determined by personal medical history, clinical examination including vital signs and clinically acceptable results of laboratory examinations (including serological tests).
8. Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording.
9. Subjects having a normal or clinically not significant chest X-Ray (P/A view).
10. A negative alcohol breathe test result.
11. Subject able to communicate effectively and provide written informed consent.
12. Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by ethics committee.
13. Subjects that can provide adequate evidence of their identity.
14. Availability of volunteer for the entire study duration.
15. Ability to fast for at least 14.00 hours and consume standard meals.
|
|
| ExclusionCriteria |
| Details |
1. Known hypersensitivity to ashwagandha or related drugs or any component of this medication.
2. Incapable of understanding the informed consent information.
3. History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological or psychiatric disease or disorder.
4. Any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within one month of starting the study.
5. History or presence of alcoholism or drug abuse.
6. History or presence of asthma, urticaria or other allergic reactions.
7. History or presence of gastric and/or duodenal ulceration.
8. History or presence of thyroid disease, adrenal dysfunction, organic intracranial lesion.
9. History or presence of cancer.
10. Difficulty with donating blood.
11. Use of any prescribed medication (including herbal remedies) during the two weeks before the start of the study or OTC medicinal products (including herbal remedies) during the week prior to study initiation and throughout the study.
12. Use of medications such as benzodiazepines, anticonvulsants, or barbiturates during one month before the start of the study and throughout the study.
13. Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study.
14. Subject consumed tobacco/ tobacco containing products, pan or pan masala, gutkha, masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study.
15. Subject consumed caffeine and /or xanthine-containing foods or beverages (i.e. coffee, tea, chocolate, and caffeine-containing sodas, colas, etc.) and grape fruit juice and poppy containing foods for at least 48.00 hours prior to initiation of the study and throughout the study.
16. Major illness during the 90 days before screening.
17. Participation in a drug research study within 90 days of screening.
18. Donation of blood within 90 days of screening.
19. Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C and VDRL.
20. History or presence of easy bruising or bleeding.
21. Abnormal diet pattern for whatever reason (e.g. low sodium, fasting, and high protein diets) during the four weeks preceding the study.
22. Pregnant woman and nursing mothers.
23. Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing.
24. Woman of child bearing age who do not agree to follow a reliable method of contraception during study period.
25. Male volunteer unwilling to employ appropriate contraceptive measures to ensure that his partner will not get pregnant during the study till 07 days after the completion of study.
26. Male volunteer willing to donate sperms during the study till 07 days after the completion of study.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the oral bioavailability of actives of Ashwagandha (Withanolides) in the blood plasma after intake of the four formulations of Ashwagandha. |
Pre-dose (0 hour), 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 9.00, 12.00, 16.00 and 24.00 hours post-dose. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the bioequivalence of the four formulations of Ashwagandha standardized to contain 185 mg of total withanolides. |
Pre-dose (0 hour), 0.25, 0.50, 0.75, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 9.00, 12.00, 16.00 and 24.00 hours post-dose. |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/10/2020 |
| Date of Study Completion (India) |
16/12/2020 |
| 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
|
This study will evaluate the bioavailability and bioequivalence of actives of Ashwagandha (Withanolides) in blood plasma from oral consumption of four formulations of Ashwagandha (Withania somnifera) extracts in capsule form. The sample size of the study will be 16 healthy volunteers who give voluntary informed consent. The screening period will be within 21 days prior to day of dosing. Subjects will be housed in the clinical facility from not less than 11.00 hours pre-dose to ensure at least 10.00 hours fasting prior to administration of investigational product and will remain in the facility post-dose until at least 24.00 hours in each period, provided they are not suffering from any adverse event. There will be a total of 4 such periods. There will be a washout period of at least 07 days between each dose administration. In each period there will be a total of 17 blood collection at different time points from a participant. |