| CTRI Number |
CTRI/2023/05/052465 [Registered on: 10/05/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial on subjects suffering from insomnia disorder. |
|
Scientific Title of Study
|
Clinical validation of efficacy and safety of Blessful Sleep Gummies (BSG)
in subjects suffering from insomnia disorder. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/22-23/017 Version:1.00 dated 28 March 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V G Vaidya |
| Designation |
Managing Trustee |
| Affiliation |
Lokmanya Medical Research Centre and Hospital |
| Address |
Fourth floor OPD 401 314 B Telco Road Chinchwad
Pune
MAHARASHTRA
411033
India
Pune
MAHARASHTRA
411033
India |
| Phone |
9822057766 |
| Fax |
- |
| Email |
vgvclinical@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Prachi Awasthi |
| Designation |
Research Analyst |
| Affiliation |
Aesthetic Nutrition Pvt. Ltd. |
| Address |
5th Floor, Plot No 468, Udyog Vihar, Phase III, Gurugram, Haryana
Gurgaon
HARYANA
122016
India |
| Phone |
8588930646 |
| Fax |
- |
| Email |
prachi.a@powergummies.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Ekta Pathania |
| Designation |
Senior Production Manager |
| Affiliation |
Aesthetic Nutrition Pvt. Ltd. |
| Address |
Plot Number 59, Sector 5, IMT, Manesar, India
Gurgaon
HARYANA
122052
India |
| Phone |
8219813394 |
| Fax |
- |
| Email |
ekta.p@powergummies.com |
|
|
Source of Monetary or Material Support
|
| Aesthetic Nutrition Pvt. Ltd. Plot Number 59, Sector 5, IMT, Manesar-122052, India |
|
|
Primary Sponsor
|
| Name |
Aesthetic Nutrition Pvt Ltd |
| Address |
Plot Number 59, Sector 5, IMT, Manesar-122052, India |
| Type of Sponsor |
Other [Nutraceutical manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Manjit Sisode |
Janseva Hospital |
2nd floor, Datta Mandir Chowk, Deopur, Dhule-424005
Dhule
MAHARASHTRA |
9850001222
-
manjit.sisode8888@gmail.com |
| Dr V G Vaidya |
Lokmanya Medical Research Centre and Hospital |
forth floor OPD 401 314
B Telco Road
Chinchwad Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9822057766
-
vgvclinical@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
BSG along with Cognitive Behavioral Therapy for Insomnia (CBT-I) |
2 BSG per day after dinner along with CBT-I for 2 weeks. Gummies
will be taken 30-60 minutes before going to bed. |
| Comparator Agent |
CBT-I |
CBT-I for 2 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female aged 25-40 years (both inclusive) at the time of obtaining written informed consent; 2. Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders, text revision (DSM-V-TR); 3. Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate; 4. Subjects with a diagnosis of mild or moderate depression (patients’ health questionnaire (PHQ-9) score of less than or equal to 14); 5. Subjects with a diagnosis of mild or moderate generalized anxiety disorder (GAD) -7 questionnaire score of less than or equal to 10; 6. Subjects willing to sign inform consent form;7. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period;8. Willing to limit alcohol, caffeine, and nicotine consumption while in the study. |
|
| ExclusionCriteria |
| Details |
1. Difficulty sleeping due to a medical condition;
2. History of a neurological disorder;3. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication;
4. On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score more than or equal to 15 and GAD-7 score more than or equal to 11 scales); 5. History of substance abuse or dependence;6. History or current evidence of a clinically significant cardiovascular disorder at pre-study visit;7.Taking certain prohibited medications;8. Consumption of more than 10 cigarettes a day; 9. History of malignancy less than or equal to 5 years prior to signing informed consent and current evidence of cancer;10. Known hypersensitivity to any ingredients of BSG;
11. Other conditions, which in the opinion of the investigators, makes the subject unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Subject-reported time to sleep onset (as per subject sleep diary) at day 7 and day 14.
2. Sleep latency (as per subject sleep diary) at day 7 and day 14.
3. Sleep efficiency (Total sleep time divided by time in bed into 100) derived from subject sleep diary at day 7 and day 14.
4. Sleep efficiency (Deep sleep, light sleep and REM sleep duration), overall sleep score by actigraphy for 10 subjects (5 subjects in each group) at screening and day 14. |
Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Outcomes from subject sleep diary (Subject-reported total sleep time, Subject- reported number of awakenings, Subject -reported wake time after sleep onset) at day 7 and day 14.
2. Severity of insomnia using Insomnia Severity Index Scale at screening and day 14.
3. Daytime fatigue using Fatigue Severity Scale (FSS) at screening and day 14.
4. Measurements of stress on perceived stress scale at screening and day 14.
5. Measurement of mood on POMS scale (Profile of mood state questionnaire) at screening and day 14.
6. Cortisol and dopamine levels at screening and day 14. |
Screening Day, Visit 1(Day 1), Visit 2(Day 7), Visit 3(Day 14), Visit 4(Day 21) |
|
|
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)
|
16/05/2023 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Prevalence of sleep disorder/deprivation is increasing at the alarming levels among the Indian population. Insufficient sleep is a public health epidemic that is often unrecognized and under-reported. The effects of sleep disorders on the body are widely varied across multiple body systems. There are pharmacotherapies to aid in sleep but often are accompanied by adverse events. The micronutrient and phytotherapy supplementation are gaining interest as a sustainable way of handling sleep disorders. In order to validate the hypothesis of usefulness of such interventions in insomnia disorder, BSG is a novel formula tasty gummy format, rather than a pill for better subject compliance.
It is comprising herbal extract, vitamin B6 along with melatonin, which are thought to be effective in management of insomnia and related symptoms.
The present research is an attempt of clinical validation of BSG in subjects suffering from insomnia disorder. With the present research we can apply the knowledge from phytotherapy and nutrition along with the clinical trials to address important medical needs in insomnia subjects to improve sleep. There is need to do primary translational work earliest & focus at some targeted aim and come up with a formulation for same to improve sleep quality and quantity, to improve daytime function, reduction of distress and changes associated with insomnia like fatigue, perceived stress, mood, cortisol and dopamine levels. Which could be achieved through the present research. We can utilize these outcomes to develop a strategy for treating insomnia in more appropriate and assured way. |