| CTRI Number |
CTRI/2026/01/101314 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A Clinical Study to Assess the Safety and Benefits of Pistamel™ for Stress Reduction and Better Sleep in Adults. |
|
Scientific Title of Study
|
A Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Safety and Efficacy of PistamelTM to Manage Stress and Improve Sleep Quality in Adults. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BHC/PT/25/01 Version 1.0 Dated 30 DEC 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gurudev S |
| Designation |
general physician |
| Affiliation |
Gurudev Clinic |
| Address |
C/o Gurudev Clinic, Bazaar Road Old Town, Yelahanka, Bangalore-560064, Karnataka
Bangalore
KARNATAKA
560064
India |
| Phone |
9446105917 |
| Fax |
|
| Email |
drsgrdv1980@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sravani |
| Designation |
Manager (Technical Business Development) |
| Affiliation |
Botanic Healthcare Pvt. Ltd |
| Address |
Plot No.16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076
Hyderabad
TELANGANA
500076
India |
| Phone |
7995688815 |
| Fax |
|
| Email |
research1@botanichealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr HN Shivaprasad |
| Designation |
Chief Scientific Officer |
| Affiliation |
Botanic Healthcare Private limited |
| Address |
Plot No.16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076
Hyderabad
TELANGANA
500076
India |
| Phone |
9515222461 |
| Fax |
|
| Email |
shiv@botanichealthcare.net |
|
|
Source of Monetary or Material Support
|
| Botanic Healthcare Pvt. Ltd Plot No. 16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076 |
|
|
Primary Sponsor
|
| Name |
Botanic Healthcare Pvt. Ltd |
| Address |
Plot No. 16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076 |
| Type of Sponsor |
Other [Nutraceutical Supplement Manufacturer] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Botanic Healthcare Pvt Ltd |
Plot No. 16,1,12,13, TSIIC IDA, Nacharam ,Mallapur Rd, Uppal, Malkajgiri, Hyderabad, Telangana 500076 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gurudev S |
Gurudev clinic |
Room 1, Ground floor, C/o Gurudev Clinic, Bazaar Road Old Town, Yelahanka, Bangalore-560064, Karnataka
Bangalore
KARNATAKA |
9446105917
drsgrdv1980@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pharexcel Independent Ethics Committee Pharexcel Consulting Private Limited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F51||Sleep disorders not due to a substance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
PistamelTM |
administered orally in capsule form daily after dinner, with each capsule containing 100 mg for 28 days |
| Comparator Agent |
Placebo (Cyclodextrin) |
identical in appearance to the investigational product |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
54.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female adults aged 18–54 years
2.Willing to provide written informed consent
3.Free from psychiatric conditions (except mild stress)
4.Able to read and write in English |
|
| ExclusionCriteria |
| Details |
1.Chronic alcoholics ( greater than 2 standard drinks per day)
2.Known cardiovascular disease, hypertension, liver or kidney disease
3.History of epilepsy, psychiatric conditions, or other significant medical conditions
4.Pregnant, lactating, or attempting to conceive
5.Currently participating in another clinical trial or received investigational product within 90 days
6.Taking medications other than oral contraceptives or hepatotoxic drugs (e.g., antitubercular, antiviral, paracetamol)
7.Acute narrow-angle glaucoma, prostate hypertrophy, or other chronic diseases affecting stress, sleep, or daily functioning
8.Diagnosable mental health disorder in the past 6 months or current use of psychotropic or herbal medication |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Objective sleep measures: Daily sleep diary Monitoring (Consensus Sleep Diary) recorded at baseline (one week prior to intervention) and throughout the period of intervention (Day 1-28)
i. Bedtime and wake-up time
ii. Sleep onset latency (estimated time to fall asleep)
iii. Number and duration of awakenings after sleep onset
iv. Total sleep duration
2) Improvement in sleep quality as measured by the AIS score, from baseline to the end of the study |
Screening, Day 1, Day 14, Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Changes in Serum Cortisol levels (a marker for stress and calmness) |
Day 1,Day 28 |
| 2.Changes in hs-CRP levels (a marker associated with sleep and stress) |
Day 1,Day 28 |
| 3.Improvement in QOL using the SF-36 questionnaire, |
Day 1,Day 28 |
| 4.Changes in Subject Global Assessment(SGA) and Physician Global Assessment (PGA) scores |
Day 14, Day 28 |
| 5.Change in weight and BMI throughout the study duration |
Screening, Day 1, Day 14, Day 28 |
| 6.Assessment of the safety of PistamelTM through haematological and biological evaluations, including ECG, CBC, LFT, RFT, and RBS |
Day 1, Day 28 |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
28/01/2026 |
| Date of Study Completion (India) |
25/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a randomized, double-blind, parallel, placebo-controlled interventional study designed to evaluate the safety and efficacy of Pistamel™ in managing stress and improving sleep quality in healthy adults aged 18–54 years. A total of 40 eligible subjects will be randomized in a 1:1 ratio to receive either Pistamel™ (100 mg capsule once daily after dinner) or a matching placebo (cyclodextrin) for 28 days.
The primary objective is to assess improvement in sleep quality using objective daily sleep diary parameters and subjective sleep quality measured by the Athens Insomnia Scale (AIS). Secondary objectives include evaluation of stress reduction through serum cortisol levels, changes in inflammatory marker hs-CRP, improvement in quality of life using the SF-36 questionnaire, global health assessment using SGA/PGA scores, changes in body weight and BMI, and overall safety and tolerability.
Safety assessments include monitoring of adverse events, clinical evaluations, vital signs, and laboratory investigations (CBC, LFT, RFT, ECG, and RBS) at baseline and study completion. The study includes a screening visit, baseline visit, mid-study follow-up, and a final visit over a total duration of 28 days. Statistical analyses will compare changes within and between groups using appropriate parametric or non-parametric tests, with significance set at p < 0.05. |