Clinical trial on Standardized Crocus sativus Extract in Human Volunteers

Not Applicable

• Registration Number: CTRI/2023/07/055436
• Lead Sponsor: Pharmanza Herbal Pvt. Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 25 July 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Healthy male and female human subject aged between 18 and 45 years (both inclusive);

2.Female subject must have a negative urine pregnancy test prior to the housing;

3.Females of childbearing potential agreeing to use appropriate contraceptive measures like non hormonal intrauterine device, barrier methods, spermicidal agents during the study and 07 days after completion of the study;

4.Male agreeing to use appropriate contraceptive measures like the Double Barrier method (Condom), and should not donate sperm, etc. during the study and 07 days after completion of the study;

5.Subjects with a BMI between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg;

6.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);

7.Subjects having a normal or clinically not significant 12-lead electrocardiogram (ECG) recording;

8.Subjects having a normal or clinically not significant chest X-ray (PA view);

9.A negative alcohol breath test result;

10.Subject able to communicate effectively and provide written informed consent;

11.Subjects willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee;

12.Subjects that can provide adequate evidence of their identity;

13.Availability of volunteers for the entire study duration;

14.Ability to fast for at least 14.00 hours and consume standard meals.

Exclusion Criteria

1. Known hypersensitivity to saffron (Crocus sativus) or related product or any component of this intervention;

2. Incapable of understanding the informed consent information;

3. Clinically significant medical condition, such as, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease), or uncontrolled haematological abnormalities;

4. Any treatment which could bring about induction or inhibition of the 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, or 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 before study initiation and throughout the study;

12. Use of medications such as benzodiazepines, anticonvulsants, or barbiturates for 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, and masala (containing beetle nut and tobacco) for at least 48.00 hours before 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 grapefruit juice and poppy-containing foods for at least 48.00 hours before 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. Females of childbearing potential with any one of the following 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.

iv. Female volunteers 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;

23. Pregnant women and nursing mothers;

24. Male and females of childbearing potential unwilling to employ appropriate and reliable method of contraception during the study till 07 days after the completion of the study;

25. Male volunteers willing to donate sperm during the study till 07 days after the completion of the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study will be to calculate <br/ ><br>1. Plasma pharmacokinetic parameters: Cmax, AUC0-t, AUC0-infinity, Tmax, Kel, t1/2, etc. from concentration Vs. time data. <br/ ><br>Timepoint: Pharmacokinetic blood samples will be collected at pre-dose [within 45 min before IP administration] & post-dose at 10, 15, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240, 300, 360, 720, 1440 min. (Total 17 Time points).

Secondary Outcome Measures

Name	Time	Method
The tolerability & safety of the intervention will be assessed by evaluating: <br/ ><br>1.Screening, pre-dose, and post-dose vital signs. <br/ ><br>2.Clinical examination, ECG, Chest X-ray, clinical laboratory testing (hematology, blood chemistry, liver function test (LFT), kidney function test (KFT), and other enzyme tests and urinalysis). <br/ ><br>3.Adverse events, serious adverse events throughout the study. <br/ ><br>4.Tolerability of the investigational product from administration to end of the study. <br/ ><br>Timepoint: From screening to end of the study