| CTRI Number |
CTRI/2025/02/079862 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical study to assess the safety and efficacy of Melostacia Gold(pistachio extract) to manage stress and improve sleep quality in adults. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Melostacio Gold (Pistachio extract) to Manage Stress and Improve Sleep Quality in Adults. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BH/MG/24 Version 1.1 dated 11 Dec 2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S S V V Narasinga Rao |
| Designation |
Asst. Professor of Medicine |
| Affiliation |
Government Medical College & Government General Hospital (Old RIMSGGH) |
| Address |
OPD No 13 First Floor, Department of Medicine,
Government Medical College & Government General Hospital (Old RIMSGGH)
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
9908611119 |
| Fax |
|
| Email |
drnarasingaraossvv@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr H N Shivaprasad |
| Designation |
Director Global Business Development |
| Affiliation |
Botanic Healthcare Pvt Ltd |
| Address |
Department of Research and Development
Corporate Office Center 16 1 12 and 13 TSIIC IDA Nacharam
Hyderabad
TELANGANA
500076
India |
| Phone |
9515222461 |
| Fax |
|
| Email |
shiv@botanichealthcare.net |
|
Details of Contact Person
Public Query
|
| Name |
T Sravani |
| Designation |
Manager Technical Business Development Department |
| Affiliation |
Botanic Healthcare Pvt Ltd |
| Address |
Department of Research and Development
Corporate Office and R and D Center 16 1 12 and 13 TSIIC IDA Nacharam
Hyderabad
TELANGANA
500076
India |
| Phone |
7995688815 |
| Fax |
|
| Email |
research1@botanichealthcare.net |
|
|
Source of Monetary or Material Support
|
| Botanic Healthcare Pvt Ltd
Corporate Office Center 16 1 12 and 13 TSIIC IDA Nacharam
Telangana 500076 Hyderabad India |
|
|
Primary Sponsor
|
| Name |
Botanic Healthcare Pvt Ltd |
| Address |
Corporate Office and R and D Center 16 1 12 and 13 TSIIC IDA Nacharam |
| 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 S S V V Narasinga Rao |
Government Medical College & Government General Hospital (Old RIMSGGH) |
OPD No 13, First Floor, Department of Medicine,
Government Medical College & Government General Hospital (Old RIMSGGH)
Hyderabad
TELANGANA |
9908611119
drnarasingaraossvv@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Government General Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Sleep and Stress |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melostacio Gold |
Once Daily, With water, after dinner for 28 days |
| Comparator Agent |
Placebo |
Once Daily, with water, after dinner for 28 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
a) Male and female adults aged between 18 and 54 years.
b) Adult subjects who are willing to provide written informed consent to participate in the study.
c) Free from psychiatric conditions, with the exception of mild stress.
d) Capable of reading and writing in English.
|
|
| ExclusionCriteria |
| Details |
a) Subjects with insomnia, sleep disorders, or chronic stress.
b) Chronic alcoholics consuming more than 2 standard pegs per day.
c) Subjects with known hypertension or other cardiovascular diseases.
d) Subjects with a history of liver diseases, kidney diseases, psychiatric conditions, epilepsy, or any other relevant medical conditions.
e) Subjects unwilling or unable to comply with the study protocol.
f) Subjects currently participating in another clinical trial or who have received any investigational product (IP) within 90 days prior to Visit 1 (Screening).
g) Subjects who withdraw their written informed consent at any point.
h) Subjects currently taking medications other than oral contraceptives.
i) Subjects on hepatotoxic medications, such as antitubercular medications, antiviral medications, or paracetamol.
j) Pregnant women, those attempting to conceive, or lactating women.
k) Individuals with acute narrow-angle glaucoma, prostate hypertrophy, or any cardiovascular, endocrine, renal, or other chronic diseases that could influence stress or anxiety or restrict normal daily functioning.
l) Individuals with any diagnosable mental health disorder in the past 6 months (as assessed by the Mini International Neuropsychiatric Interview 6.0) or those currently taking psychotropic medications or other herbal preparations. |
|
|
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 |
| Mean change in stress levels from baseline to the end of the study |
Screening/Baseline,Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Serum Cortisol levels |
Baseline(Day 1) and Day 28 |
| hs-CRP levels |
Baseline(Day 1) and Day 28 |
| Improvement in Quality of Life (QOL) using the SF-36 |
Baseline(Day 1) and Day 28 |
| Subject Global Assessment (SGA) |
Day 14 and Day 28 |
| Physician Global Assessment (PGA) scores |
Day 14 and Day 28 |
| Change in weight and BMI |
Screening/Baseline, Day 14, Day 28 |
| Assessment of the safety of Melostacio Gold through hematological and biological evaluations, including ECG, Complete Blood Count (CBC), Liver Function Tests (LFT), Renal Function Tests (RFT), and Random Blood Sugar (RBS). |
Baseline (Day 1) and Day 28 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
14/02/2025 |
| 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="4"
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
|
This study aims to evaluate the efficacy of pistachio supplementation in enhancing sleep quality and addressing stress-related biomarkers, filling a critical gap in research by providing evidence for its potential therapeutic role in sleep health and overall well-being. |