Pharmacokinetic Evaluation of formulations Containing Bacopa Monnieri Extract Capsules in Healthy Human Volunteers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- PHARMANZA HERBAL PVT LTD
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Plasma Pharmacokinetics parameters like Cmax, Tmax, AUC0-t,
Study Overview
Brief Summary
The rationale for conducting a clinical trial on standardized Brahmi (Bacopa monnieri) extract in healthy male and female volunteers is grounded in the rich pharmacological profile and historical use of this herbal extract. Brahmi, a traditional medicinal herb with a legacy spanning over 3000 years, is recognized for its cognitive-enhancing properties and diverse pharmacological activities, including neuroprotection, antioxidant, adaptogenic, and anti-inflammatory effects. The active ingredients of Brahmi, particularly Bacosides A and B, have demonstrated neuropharmacological and nootropic effects through comprehensive preclinical studies and clinical studies. Importantly, the safety of standardized Brahmi extract has been well-established through toxicity studies for human consumption. The safety profiles assessed in these trials, combined with the approval by the FSSAI as a nutraceutical, reinforce the Brahmi’s safety and potential benefits. Given the growing interest nutraceuticals worldwide, the proposed clinical trial aims to fill a crucial gap in understanding the pharmacokinetic profile of standardized Brahmi extract capsules in humans. By evaluating parameters such as Cmax, AUC, Tmax, and others, , the study seeks to elucidate how the body processes and absorbs these active compounds. Safety and tolerability assessments will provide a comprehensive overview of the extract’s impact on participants’ health. Understanding these parameters is essential for optimizing dosing regimens and ensuring consistent therapeutic outcomes. This study’s design as an open-label, single-dose, non-randomized trial aligns with the objective of characterizing the concentration-time profiles of Brahmi extract in a controlled setting. The inclusion criteria, stringent fasting requirements, and standardized fluid intake protocols ensure homogeneity among the study participants, enhancing the reliability of the outcomes. In summary, this pharmacokinetic study is strategically positioned to contribute valuable insights into the pharmacokinetics, safety, and tolerability of standardized Bacopa monnieri Extract Capsules after acute oral administration in healthy, adult human individuals under fasting conditions to advance the understanding of scientific and clinical community about this traditional herbal remedy in a modern context
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 45.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Healthy male and female participants aged between 18 and 45 years (both inclusive);
- •Female participants must have a negative urine pregnancy test prior to housing;
- •Females of childbearing potential agree to use appropriate contraceptive measures like non-hormonal intrauterine devices, barrier methods, and spermicidal agents during the study and 07 days after completion of the study;
- •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.
- •Participants with a BMI between 18.50-30.00 kg/m2 and body mass, not less than 50.00 kg.
- •Participants in normal health as determined by personal medical history, clinical examination including vital signs, andclinically acceptable results of laboratory examinations (including serological tests).
- •Participants having a normal or clinically not significant 12- lead electrocardiogram (ECG) recording.
- •Participants having a normal or clinically not significant chest x-ray (P/A view).
- •A negative alcohol breath test result at housing.
- •Participants willing to adhere to the protocol requirements as evidenced by written informed consent approved by the ethics committee.
- •Participants that can provide adequate evidence of their identity;
- •Availability of volunteers for the entire study duration.
- •Ability to fast for at least 14.00 hours and consume standard meals.
Exclusion Criteria
- •Known hypersensitivity to Bacopa monnieri or related drugs or any component of this medication;
- •Incapable of understanding the informed consent information;
- •History or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological, or psychiatric disease or disorder;
- •Any treatment that could induce or inhibit the hepatic microsomal enzyme system within one month of starting the study;
- •History or presence of alcoholism or drug abuse;
- •History or presence of asthma, urticaria, or other allergic reactions;
- •History or presence of gastric and/or duodenal ulceration;
- •History or presence of thyroid disease, adrenal dysfunction, or organic intracranial lesion;
- •History or presence of cancer;
- •Difficulty with donating blood;
- •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;
- •Use of medications such as tricyclic antidepressants, benzodiazepines, anticonvulsants, or barbiturates for one month before the start of the study and throughout the study;
- •Smokers who smoke 9 or more cigarettes/day or inability to abstain during the study;
- •Participant consumed tobacco/tobacco-containing products, pan or pan masala, gutkha, and masala (containing beetle nut and tobacco) for at least 48.00 hours prior to initiation of the study and throughout the study;
- •Participant consumed caffeine and /or xanthine-containing foods or beverages (i.e., coffee, tea, chocolate, and caffeinecontaining sodas, colas, etc.) and grapefruit juice and poppycontaining foods for at least 48.00 hours prior to initiation of the study and throughout the study;
- •Major illness during the 90 days before screening;
- •Donation of blood within 90 days of screening;
- •Positive screening test result for any one or more of the following: HIV, Hepatitis B, Hepatitis C, and VDRL;
- •History or presence of easy bruising or bleeding;
- •Abnormal diet pattern for whatever reason (e.g., low sodium, fasting, and high protein diets) during the four weeks preceding the study;
- •Male and female volunteers unwilling to employ appropriate contraceptive measures to ensure that their partner will not get pregnant during the study till 07 days after the completion of the study;
- •Male volunteers willing to donate sperm during the study till 07 days after the completion of the study;
- •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.
- •Female volunteers who have used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 07 days before dosing;
- •Pregnant women and nursing mothers.
Outcomes
Primary Outcomes
Plasma Pharmacokinetics parameters like Cmax, Tmax, AUC0-t,
Time Frame: [within 45 min before IP administration] and post-dose at 0.25, 0.50, 0.75, 1.00, | 1.50, 2.00, 3.00, 4.00, 6.00, 9.00, 12.00, and 24.00 hrs.
AUC0-infinity, t1/2, and Kel from the concentration Vs. time data.
Time Frame: [within 45 min before IP administration] and post-dose at 0.25, 0.50, 0.75, 1.00, | 1.50, 2.00, 3.00, 4.00, 6.00, 9.00, 12.00, and 24.00 hrs.
Secondary Outcomes
- 1. vital signs.(2. Chest X-ray ((P/A view))
Investigators
Dr Ram Mundhe
Gunjkar Multispeciality Hospital