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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 

 
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