CTRI/2023/07/055436 [Registered on: 20/07/2023] Trial Registered Prospectively
Last Modified On:
18/07/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Single Arm Study
Public Title of Study
Clinical trial on Standardized Crocus sativus Extract in Human Volunteers
Scientific Title of Study
Clinical Pharmacokinetic Study of Standardized Crocus sativus Extract Capsules in Healthy Human Volunteers
Trial Acronym
Nil
Secondary IDs if Any
Secondary ID
Identifier
MHC/CT/23-24/005,Version: 1.00; Dated, 20 June 2023
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr V G Vaidya
Designation
Principle Investigator
Affiliation
Lokmanya Medical Research Centre and Hospital
Address
Fourth-floor OPD 401 314 B Telco Road Chinchwad Pune
Pune MAHARASHTRA 411039 India
Phone
9822057766
Fax
-
Email
vgvclinical@gmail.com
Details of Contact Person Scientific Query
Name
Dr Siddharth J Modi
Designation
Assistant Manager
Affiliation
Pharmanza Herbal Pvt. Ltd.
Address
Plot No. 214, Borsad-Tarapur Road, Nr. Vadadla Patiya, At & PO: Kaniya-388430, Ta: Petlad
Anand GUJARAT 388430 India
Phone
8487941016
Fax
-
Email
rdbiotech@pharmanza.com
Details of Contact Person Public Query
Name
Dr Siddharth J Modi
Designation
Assistant Manager
Affiliation
Pharmanza Herbal Pvt. Ltd.
Address
Plot No. 214, Borsad-Tarapur Road, Nr. Vadadla Patiya, At & PO: Kaniya-388430, Ta: Petlad
Anand GUJARAT 388430 India
Phone
8487941016
Fax
-
Email
rdbiotech@pharmanza.com
Source of Monetary or Material Support
Pharmanza Herbal Pvt. Ltd.Plot # 214, Borsad-Tarapur Road,
Nr. Vadadla Patiya, At & PO: Kaniya-388430, Ta: Petlad, Dist: Anand (Gujarat) India.
Primary Sponsor
Name
Pharmanza Herbal Pvt. Ltd
Address
Plot # 214, Borsad-Tarapur Road, Nr. Vadadla Patiya, At & PO: Kaniya-388430, Ta: Petlad, Dist: Anand (Gujarat) India.
Type of Sponsor
Pharmaceutical industry-Indian
Details of Secondary Sponsor
Name
Address
Nil
Nil
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Ninad Naik
Lokmanya Medical Research Centre
Fourth-floor OPD
401-314 B Telco Road
Chinchwad Pune Pune MAHARASHTRA
9637785567 - naikninaad@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
The Institutional Ethics Committee of Lokmanya Medical Research Centre
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Healthy Human Volunteers
Healthy Human Volunteers
Intervention / Comparator Agent
Type
Name
Details
Intervention
Crocus sativus extract capsule
20 mg single dose (two 10 mg capsules in sequence) of Crocus sativus extract capsules
Comparator Agent
Nil
Nil
Inclusion Criteria
Age From
18.00 Year(s)
Age To
45.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
The primary endpoint of the study will be to calculate
1. Plasma pharmacokinetic parameters: Cmax, AUC0-t, AUC0-infinity, Tmax, Kel, t1/2, etc. from concentration Vs. time data.
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
Outcome
TimePoints
The tolerability & safety of the intervention will be assessed by evaluating:
1. Screening, pre-dose, and post-dose vital signs.
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).
3. Adverse events, serious adverse events throughout the study.
4. Tolerability of the investigational product from administration to end of the study.
From screening to end of the study
Target Sample Size
Total Sample Size="18" Sample Size from India="18" 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)
30/07/2023
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="2" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Crocus sativus L., also known as saffron, is a popular food condiment with a high aroma, deep color, and long and thick threads (stigmas). Saffron is cultivated in many countries, including India (Kashmir saffron), Spain (Spanish saffron), Iran (Persian saffron), Afghanistan, France, Morocco, and Greece. It is popular folklore and Indian traditional medicine used in the treatment of various health conditions such as eye health, skin disorders, digestive ailments, women’s health, and others In recent studies, Crocus sativus was found to have prominent action against neurodegenerative disorders, namely Alzheimer’s (AD), Parkinson’s disease, dementia, and anxiety, due to the presence of bioactive constituents’ carotenoids (Crocin, Crocetin) and apocarotenoids (Picrocrocin, Safranal), etc. The growing number of clinical trials involving saffron extract for various therapeutic uses such as age-related macular degeneration, anxiety, mood disorder, and so on, as well as the growing interest in phytomedicine, emphasize the importance of conducting pharmacokinetic studies for saffron and its bioactive phytoconstituents.
Thus, single dose phamacokinetic study of standerdized Crocus sativus extract in human provide crucial data on its absorption, distribution, metabolism, and elimination. This knowledge can contribute to the development of safer and more effective dosing strategies, aid in understanding the therapeutic potential of Crocus sativus, and support evidence-based decision-making regarding its clinical use.
The investigational product capsules (10 mg) is formulated from standerdized Crocussativus stigma extract. The single dose 20 mg (2*10 mg capsules in sequence) will be administred to healthy subjects.
Single dose pharmacokinetics is sufficient at this stage of development; hence, the proposed study is planned. Subject’s disease condition, liver function, kidney function etc. greatly affect pharmacokinetics of any active ingredients; hence, healthy human subjects are always considered the best population to study pharmacokinetics of any active ingredients of such products.
The present research is an attempt of exploration of the pharmacokinetic profile along with safety and tolerability of standardized Crocus sativus extract capsule and its constituents after acute oral administration in healthy, adult human subjects under fasting conditions