| CTRI Number |
CTRI/2024/01/061052 [Registered on: 02/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical study on EL STI 01 in stress and insomnia |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of EL STI 01 in healthy individuals having stress and insomnia- A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective, Clinical Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EMIL/SPI/2023/1, Version 1.0, 27th Jul 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vijayalaxmi Sujay Patil |
| Designation |
Associate Professor |
| Affiliation |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
| Address |
Department of Kayachikitsa, OPD No. 2, ground floor,
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune MAHARASHTRA
Pune
MAHARASHTRA
411028
India |
| Phone |
9665429186 |
| Fax |
|
| Email |
drvijayalaxmispatil@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai 400064
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Emil Pharmaceutical Industries Private Limited,
301, Western Edge 1, Above Metro Mall, Magathane, Western Express Highway, Kulupwadi, Borivali East, Mumbai, Maharashtra 400066 India.
|
|
|
Primary Sponsor
|
| Name |
Emil Pharmaceutical Industries Private Limited |
| Address |
301, Western Edge 1, Above Metro Mall, Magathane, Western Express Highway, Kulupwadi, Borivali East, Mumbai, Maharashtra 400066 India. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishir Pande |
Ayurved Seva Sangh’s, Ayurved Mahavidyalaya & Rugnalaya |
Ayurved Sanshodhan Vibhag, OPD No 9, Ground Floor, Ayurved Seva Sangh’s Ayurved Mahavidyalaya, Ganeshwadi, Panchvati, Nashik, Maharashtra – 422003
Nashik
MAHARASHTRA |
09146030818
shishir.nsk@gmail.com |
| Dr Vijayalaxmi Sujay Patil |
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra |
Department of Kayachikitsa, OPD No. 2, ground floor,
MAMs Sumatibhai Shah Ayurved Mahavidyalaya and Sane Guruji Arogya Kendra, Malwadi Hadapsar, Pune MAHARASHTRA
Pune
MAHARASHTRA |
09665429186
drvijayalaxmispatil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Maharashtra Aarogya Mandals Sumatibhai Shah Ayurved Mahavidyalaya and Ayurved Hospital Sane Guruji Arogya Kendra, Hadapsar, Pune |
Approved |
| Institutional Ethics Committee, Ayurved Seva Sangh Ayurved Mahavidyalaya, Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress and Insomnia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
EL STI 01 Tablet |
Key ingredients of EL STI 01 Tablet are Melatonin, Valeriana wallichii extract, L-Tryptophan, L-Threonine, Magnesium, Nutmeg extract Dose: Participants will be asked to take given product in a dose of 2 tablets at bedtime daily with water for 30 days.
|
| Comparator Agent |
Placebo Tablet |
Dose: Participants will be asked to take given product in a dose of 2 tablets at bedtime daily with water for 30 days. |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy Participants who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS)
2. Healthy Participants having insomnia based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-5)
3.Insomnia Severity Index more than 7 and greater than 21
4. Participants willing to sign inform consent form
5.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
|
|
| ExclusionCriteria |
| Details |
1. History or diagnosis of another sleep disorder
2. Difficulty sleeping due to a medical condition
3. History of a neurological disorder
4. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication
5. On going depression and generalized anxiety disorder
6. History of substance abuse or dependence
7. Taking certain prohibited medications [opium, cannabis (marijuana) and methamphetamines]
8. Participants with habit of smoking Cigarette etc.
9. Participants with known history of hepatitis B and or C, diabetes mellitus, hypertension, cancer
10. History of malignancy less than or equal to 5 years prior to signing informed consent
11. Known hypersensitivity to any of the ingredients of study products
12. Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his or her participation in, and completion of the protocol
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in participant-reported total sleep
2. Change in stress on perceived stress scale
|
Screening Visit Baseline visit, Day 15, Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. Changes in sleep efficiency
3. Change in pre and post-serum cortisol (morning) levels
4. Change in quality of Life on the GHQ28 Scale
5. Change in participant-reported time to sleep onset
6. Change in severity of Insomnia using Insomnia Severity Index
7. Change in daytime fatigue using Fatigue Severity Scale (FSS)
8. Change in daytime mood, ability to function at work, concentration and memory
9. Change in quality of sleep on Pittsburgh Sleep Quality Index (PSQI)
10. Global assessment for overall change by investigator and by participant
11. Assessment of tolerability of study products
12. Pre and post- study product consumption laboratory investigations
|
Screening Visit Baseline visit, Day 15, Day 30 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "62"
Final Enrollment numbers achieved (India)="62" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
09/01/2024 |
| Date of Study Completion (India) |
31/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
Modification(s)
|
It is a randomized, double blind, placebo controlled, multi-centric, interventional, prospective, clinical study to evaluate efficacy and safety of EL/STI/01 in healthy individuals having stress and insomnia. The study will be carried out in 2 to 3 centers across India. Primary objectives of the study will be to assess change in participant-reported total sleep and change in stress on perceived stress scale. Secondary objectives of the study will be to assess changes in sleep efficiency, pre and post-serum cortisol (morning) levels, quality of Life on the GHQ28 Scale, participant-reported time to sleep onset, severity of Insomnia using Insomnia Severity Index, daytime fatigue using Fatigue Severity Scale (FSS), daytime mood, ability to function at work, concentration and memory, quality of sleep on Pittsburgh Sleep Quality Index (PSQI), global assessment for overall change by investigator and by participant, assessment of tolerability of study products and pre and post- study product consumption laboratory investigations.
Summary of Results:
The study concludes that EL/STI/01 which is a combination of herbs and
nutraceutical ingredients showed significant stress reducing effects as
observed on various scales. Also, there was a significant improvement in the
sleep related parameters like total sleep time, sleep efficiency, sleep onset
time, and associated symptoms like day time mood, ability to work, concentration,
memory. A significant reduction in Sr. Cortisol was observed with 30 days use
of EL/STI/01. No adverse event was reported due to the consumption of EL/STI/01
and the same was well tolerated. Laboratory related safety parameters also did
not show any significant change with the use of EL/STI/01 providing evidence of
safety. EL/STI/01 therefore can be effectively and safely recommended for the
management of stress related and sleep related conditions.
|