| CTRI Number |
CTRI/2025/09/094856 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on the Pharmacokinetics and Behavior of Bacopa monnieri Capsules in the Human Body |
|
Scientific Title of Study
|
Pharmacokinetic Evaluation of formulations Containing Bacopa Monnieri Extract Capsules in Healthy Human Volunteers. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/25-26/009 Version: 1.00; Dated, 24 June 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ram Mundhe |
| Designation |
Principal Investigator |
| Affiliation |
Gunjkar Multispeciality Hospital |
| Address |
Ground Floor Gunjkar Multispeciality Hospital, Spine Road Shivtej Nagar, Chinchwad
-
Pune
MAHARASHTRA
411019
India |
| Phone |
8454859082 |
| Fax |
- |
| Email |
drrammudhe.gunjkarresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raj Bhatt |
| Designation |
Research scientist |
| Affiliation |
PHARMANZA HERBAL PVT. LTD., |
| Address |
214, Borsad-Tarapur Road,
Nr. Vadadla Patiya, At&PO: KANIYA
-
Anand
GUJARAT
388430
India |
| Phone |
9723223672 |
| Fax |
- |
| Email |
crdoc@pharmanza.com |
|
Details of Contact Person
Public Query
|
| Name |
Raj Bhatt |
| Designation |
Research scientist |
| Affiliation |
PHARMANZA HERBAL PVT. LTD., |
| Address |
214, Borsad-Tarapur Road,
Nr. Vadadla Patiya, At&PO: KANIYA
-
Anand
GUJARAT
388430
India |
| Phone |
9723223672 |
| Fax |
- |
| Email |
crdoc@pharmanza.com |
|
|
Source of Monetary or Material Support
|
| PHARMANZA HERBAL PVT. LTD.
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 |
214, Borsad-Tarapur Road,
Nr. Vadadla Patiya, At&PO: KANIYA
38 8430Ta: Petlad, Dist: Anand (Gujarat) India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Ram Mundhe |
Gunjkar Multispeciality Hospital |
Ground Floor Gunjkar Multispeciality Hospital Spine Road Shivtej
nagar chinchwad
pune 411019
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
08454859082
-
drrammudhe.gunjkarresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sangvi Multispecialty Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Adults |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
300 mg Bacopa monnieri Extract Capsules (Bacognize®) Single Dose Only |
| Intervention |
Group B |
300 mg Bacopa monnieri Extract Capsules (NextBac™)Single Dose Only
|
| 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 participants aged between 18 and 45
years (both inclusive);
2. Female participants must have a negative urine pregnancy test
prior to housing;
3. 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;
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. Participants with a BMI between 18.50-30.00 kg/m2 and body
mass, not less than 50.00 kg.
6. Participants in normal health as determined by personal
medical history, clinical examination including vital signs, andclinically acceptable results of laboratory examinations
(including serological tests).
7. Participants having a normal or clinically not significant 12-
lead electrocardiogram (ECG) recording.
8. Participants having a normal or clinically not significant chest
x-ray (P/A view).
9. A negative alcohol breath test result at housing.
10. Participant able to communicate effectively and provide
written informed consent.
11. Participants willing to adhere to the protocol requirements as
evidenced by written informed consent approved by the ethics
committee.
12. Participants 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 Bacopa monnieri 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 that could induce or inhibit 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 prior to study initiation and throughout the study;
12. Use of medications such as tricyclic antidepressants,
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. 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;
15. 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;
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. 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;
23. Male volunteers willing to donate sperm during the study till
07 days after the completion of the study;
24. 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 have used implanted or injected
hormonal contraceptives anytime during the 6 months prior to
study or used hormonal contraceptives within 07 days before
dosing;
25. Pregnant women and nursing mothers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plasma Pharmacokinetics parameters like Cmax, Tmax, AUC0-t,
AUC0-infinity, t1/2, and Kel from the concentration Vs. time data. |
[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 Outcome
|
| Outcome |
TimePoints |
1. vital signs.
2. Chest X-ray ((P/A view)
3. Clinical examination, ECGs, & clinical laboratory testing
(hematology, blood chemistry, & urinalysis)
4. Adverse events, serious adverse events
5. Tolerability of the investigational product |
1. Screening & Day 1 (pre-dose, & post-dose)
2. At Screening
3. At Screening & Day 2
4. From Screening to End of the Study
5. At Day 1 & Day 2 |
|
|
Target Sample Size
|
Total Sample Size="12"
Sample Size from India="12"
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)
|
29/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/09/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
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 |