| CTRI Number |
CTRI/2022/09/045737 [Registered on: 21/09/2022] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| 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 Trial of Sleepnite Tablet in patients suffering from Insomnia |
|
Scientific Title of Study
|
Evaluation of efficacy of nutritional formula Sleepnite Tablet in patients suffering from Insomnia- A randomized placebo controlled clinical trial. |
| Trial Acronym |
Nil |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| MHC/CT/22-23/003 (Ver 2.0 dated, 29th October 2022) |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Arabinda Brahma |
| Designation |
Consultant Psychiatrist |
| Affiliation |
Girindra sekhar clinic |
| Address |
14 Parshibagan Lane
Kolkata WEST BENGAL 700009 India |
| Phone |
9830066869 |
| Fax |
- |
| Email |
drarabindabrahma04@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Tania Dcruz |
| Designation |
Senior Medical Executive (Medical Services) |
| Affiliation |
Meyer Organics Pvt. Ltd. |
| Address |
A 303 Road No 32 Wagle Estate Thane.
Mumbai MAHARASHTRA 400 604 India |
| Phone |
912225817126 |
| Fax |
9162757002 |
| Email |
tdcruz@meyer.co.in |
|
Details of Contact Person Public Query
|
| Name |
Neepa Gaba |
| Designation |
Scientific coordinator |
| Affiliation |
Meyer Organics Pvt. Ltd. |
| Address |
A 303 Road No 32 Wagle Estate Thane.
Mumbai MAHARASHTRA 400 604 India |
| Phone |
912225817126 |
| Fax |
9162757002 |
| Email |
ngaba@meyer.co.in |
|
|
Source of Monetary or Material Support
|
| Meyer Organics Pvt. Ltd.
A-303, Road No. 32, Wagle Estate, Thane Mumbai Maharashtra 400 604 India |
|
|
Primary Sponsor
|
| Name |
Meyer Organics Pvt Ltd |
| Address |
A-303, Road No. 32, Wagle Estate, Thane, Maharashtra- 400604 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| 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 Nithin Kondapuram |
Aster Prime Hospital |
Plot no 4, Kumar Basti, behind Mythrivanam, Ameerpet, Hyderabad, 500038 Hyderabad TELANGANA |
9004089098 - nithin.kondapuram@gmail.com |
| Dr Neeta Deshpande |
Belgaum Diabetes Centre |
Maruti Galli, Belgaum,590001, India. Belgaum KARNATAKA |
9880271313 - neetarohit@gmail.com |
| Dr Arabinda Brahma |
Girindra sekhar clinic |
14 Parshibagan Lane, Kolkata 700009 Kolkata WEST BENGAL |
9830066869 - drarabindabrahma04@yahoo.com |
| Dr V G Vaidya |
Lokmanya Medical Research Centre and Hospital |
Forth floor OPD 401 314 B Telco Road Chinchwad Pune
MAHARASHTRA 411033 India
Pune MAHARASHTRA |
9822057766 - vgvclinical@gmail.com |
| Dr Harish Shetty |
Mental Health Lounge |
Sneh Samadhan Building Agarkar chowk opp Mcdonald Behind Bata Showroom Andheri East Mumbai MAHARASHTRA |
9820032178 - harish139@yahoo.com |
| Dr G Sunil Kumar |
SK Clinic and Scans |
Govt. hospital junction, Poovar. Thiruvananthapuram, 695525 Thiruvananthapuram KERALA |
8921830875 - sun786grg@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
| Royal Independent Ethics Committee |
Approved |
| Royal Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
Approved |
| Royal Pune Independent Ethics Committee |
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 |
| Comparator Agent |
Placebo with CBT-I (Cognitive Behavioral Therapy for Insomnia) |
One Placebo tablet after dinner for 60 days |
| Intervention |
Sleepnite Tablet with CBT-I (Cognitive Behavioral Therapy for Insomnia) |
One Sleepnite tablet daily after dinner for 60 days |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants aged greater than or equal to 18 and less than or equal to 65 years of both sex 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 < 21 i.e. mild to moderate;
4. Patients with a diagnosis of Mild or moderate depression (Patients’ health questionnaire (PHQ-9) score of ≤14);
5. Patients with a diagnosis of Mild or moderate Generalized anxiety disorder (Generalized anxiety disorder (GAD) -7 questionnaire score of ≤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. No history of substance use disorder other than use of nicotine and recreational use of alcohol (not having used for the last 14 days and consenting not to use the same during the period of the trial);
9. Willing to limit caffeine consumption while in the study. |
|
| ExclusionCriteria |
| Details |
1. Difficulty sleeping due to a medical condition;
2. History of a neurological disorder;
3. Lifetime history of severe mental illness;
4. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires sedating medication;
5. On-going depression and generalized anxiety disorder (diagnosis on PHQ 9 score ≥15 and GAD 7 score ≥11 scales);
6. History of substance abuse or dependence;
7. History or current evidence of a clinically significant cardiovascular disorder at pre study visit;
8. Taking certain prohibited medications;
9. Consumption of >15 cigarettes a day;
10. History of malignancy ≤5 years prior to signing informed consent;
11. Known hypersensitivity to any of the ingredients of Sleepnite tablet;
12. Other conditions, which in the opinion of the investigators, makes the patient 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
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Patient-reported total sleep time (as per patient diary).
2.Sleep latency (as per patient diary).
3.Sleep efficiency (Total sleep time divided by time in bed multiplied by 100) derived from patient diary. |
Screening, Day 30 and Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Outcomes from patient diary (Patient-reported total sleep time, Patient- reported number of awakenings, Patient -reported wake time after sleep onset).
2.Severity of Insomnia using Insomnia Severity Index Scale.
3.Daytime fatigue score using Fatigue Severity Scale (FSS).
4.Measurements of stress score on perceived stress scale.
Measurement of mood score on POMS scale (Profile of mood state questionnaire).
|
Screening, Day 30 and Day 60 |
|
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
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 3 |
|
Date of First Enrollment (India)
|
30/09/2022 |
| 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="5" 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 found to be alarming among the Indian population. COVID-19 pandemic has resulted in significant increase in insomnia. Insufficient sleep is considered to be a public health epidemic that is often unrecognized and under-reported. Burden of insomnia has been grossly underestimated. The effects of sleep disorders on the body are numerous and widely varied across multiple body systems. There are pharmacotherapies to aid in sleep but often are accompanied by huge adverse events. Recently there is lot of emphasize is to clinically validate the micronutrient and phytotherapy supplementation as a sustainable way of handling sleep disorders which are of mild to moderate severity and not secondary to any disease or disorder. In order to validate the hypothesis of usefulness of such interventions in primary insomnia, Sleepnite Tablet is a novel formula comprising herbal extracts and some assorted micronutrients, which are thought to be effective in management of insomnia and related symptoms. The present research is an attempt of clinical validation of Sleepnite Tablet in patients suffering from insomnia. 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 patients 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 and cortisol 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. |