| CTRI Number |
CTRI/2026/03/105341 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of SOBC-730 in improving memory. |
|
Scientific Title of Study
|
A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effect of SOBC-730 in improving memory function |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| WES-CT-MI -002-2026, Version 1.0 dated 04 February 2026 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D,Behind ISRO, Erumathala P.O.
Ernakulam
KERALA
683112
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Binu T Kuruvilla |
| Designation |
Chief Innovation Officer |
| Affiliation |
Arjuna Natural Private Limited |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D,Behind ISRO, Erumathala P.O.
Ernakulam
KERALA
683112
India |
| Phone |
09447818432 |
| Fax |
|
| Email |
drbinu@arjunanatural.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Giby Abraham |
| Designation |
Senior Scientist Clinical Research |
| Affiliation |
Arjuna Natural Pvt. Ltd. |
| Address |
Arjuna Innovation Centre, Clinical Trial Department, Door No. 187/D,Erumathala P.O.
Ernakulam
KERALA
682021
India |
| Phone |
09995215790 |
| Fax |
|
| Email |
giby.a@arjunanatural.com |
|
|
Source of Monetary or Material Support
|
| Arjuna Natural Pvt. Ltd., Desom P.O, Aluva, Kerala, India - 683 102 |
|
|
Primary Sponsor
|
| Name |
Arjuna Natural Pvt Ltd |
| Address |
Desom P.O, Aluva, Kerala, India - 683 102 |
| 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 S S V V Narasinga Rao |
Government Medical College & Government General Hospital |
Room No. 009, Ground
floor, Department of
General Medicine
Shanti Nagar Colony,
Balaga - 532001
Srikakulam
ANDHRA PRADESH |
9908611119
drnarasingaraossvv@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government General Hospital, Srikakulam |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
memory |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Take 1 capsule once daily in the morning for 8 weeks |
| Intervention |
SOBC-730 350 mg |
Take 1 capsule once daily in the morning for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female participant aged 18 to 65 years at the time of screening
2. Montreal Cognitive Assessment (MoCA) score between 22 and 26, inclusive, at screening
3. Subjective distractibility without ADHD diagnosis
4. Education level : over high school
5. Subjective complaints of memory difficulty, distractibility, or reduced cognitive performance
without a diagnosis of dementia
6. Ability to understand and complete digital or paper-based cognitive assessments
7. Willingness to maintain usual lifestyle habits and refrain from initiating new cognitiveenhancing supplements or medications during the study
8. Ability and willingness to comply with all trial procedures and visit schedules
9. Provision of written informed consent prior to any trial-specific procedures |
|
| ExclusionCriteria |
| Details |
1. Diagnosis of dementia, Alzheimer’s disease, or other major neurocognitive disorder
2. History of significant neurological conditions, including but not limited to stroke, epilepsy,
traumatic brain injury, brain tumor, or neurodegenerative disease
3. Severe psychiatric disorders, including major depressive disorder, schizophrenia, bipolar
disorder, alcohol dependence, or substance abuse
4. Use of medications that may interfere with cognitive outcomes within 4 weeks prior to
screening, including: Dementia treatment drugs, Thyroid hormone drugs, Central nervous system stimulants, Antipsychotics, Anticholinergic drugs, Brain metabolism enhancers
5. Diagnosed sleep disorders that may significantly affect cognitive function
6. Uncontrolled endocrine disorders, including uncontrolled diabetes or abnormal thyroid
function
7. Clinically significant abnormal laboratory values at screening, including ALT or AST greater than 3 times upper limit of normal, Hb less than or equal to 8 g per dL or platelet count less than 100,000 per mm³, eGFR less than 60 mL/min/1.73 m²
8. Uncontrolled hypertension (SBP greater than 140 mmHg or DBP greater than 90 mmHg)
9. Thyroid-stimulating hormone (TSH) levels outside the normal range for the institution.
10. Unstable angina, myocardial infarction, transient ischemic attack, or coronary interventions
including coronary artery bypass surgery within 6 months prior to the consent date.
11. Severe trauma with loss of consciousness within 6 months prior to the consent date.
12. Acute stroke within 3 months prior to the consent date
13. Shift workers
14. Alcohol consumption exceeding WHO s daily intake guidelines greater than or equal to 40 g/day for men and greater than or equal to 20
g/day for women.
15. Heavy smokers (greater than or equal to 20 cigarettes/day)
16. Heavy use greater than 300 mg/day (greater than or equal to 3 cups coffee, energy drinks)
17. Pregnant, lactating, or planning pregnancy during the study period
18. Known hypersensitivity to any component of the investigational product
19. Participation in another clinical trial within 3 months prior to screening
20. Any medical condition or circumstance that, in the opinion of the Investigator, could
interfere with study participation or interpretation of results. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of the investigational herbal product on memory function compared with placebo, as assessed by validated cognitive assessment tools. |
Baseline, Week 4, Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the effect of the investigational product on attention, executive function, and working memory. |
Baseline, Week 4, Week 8 |
| To evaluate changes in neuroendocrine biomarkers associated with cognitive function |
Baseline, Week 8 |
| To assess the safety and tolerability of the investigational product over the study duration |
Throughout the study duration |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
16/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 study is designed to evaluate the effect of SOBC-730 in improving memory. Participants meeting inclusion/exclusion criteria are enrolled into the study and randomized to receive either test product or placebo. Participants will be assessed using memory assessment scales at Baseline. The participants will be given investigational products for 8 weeks at a dose of 350mg/day. Memory assessment will be done after Week 4 and Week 8, after intake of test product and placebo. Biomarkers were assessed at Baseline and end of study.
|