| CTRI Number |
CTRI/2025/09/095263 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
30/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study for male insomnia patients |
|
Scientific Title of Study
|
A Single arm, Single blind, Multicenter, Interventional Study to evaluate the Efficacy and Safety of Naturopathic Sleeping Products in Male Patients with General Insomnia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-CT-0006-25-SUPE Version 01 24 Jun 25 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anbhazagan Ramaraju |
| Designation |
DM Psychiatry |
| Affiliation |
Delta Diabetic Centre |
| Address |
Department of Psychiatry
D 125 10th cross Thillai Nagar East
Tiruchirappalli
TAMIL NADU
620018
India |
| Phone |
9538800755 |
| Fax |
|
| Email |
dr.anbu87@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anbhazagan Ramaraju |
| Designation |
DM Psychiatry |
| Affiliation |
Delta Diabetic Centre |
| Address |
Department of Psychiatry
D 125 10th cross Thillai Nagar East
TAMIL NADU
620018
India |
| Phone |
9538800755 |
| Fax |
|
| Email |
dr.anbu87@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anbhazagan Ramaraju |
| Designation |
DM Psychiatry |
| Affiliation |
Delta Diabetic Centre |
| Address |
Department of Psychiatry
D 125 10th cross Thillai Nagar East
TAMIL NADU
620018
India |
| Phone |
9538800755 |
| Fax |
|
| Email |
dr.anbu87@gmail.com |
|
|
Source of Monetary or Material Support
|
| SleepDrops® International Limited
27 E Smales Road
East Tamaki
Auckland New Zealand |
|
|
Primary Sponsor
|
| Name |
SleepDrops® International Limited |
| Address |
27 E Smales Road
East Tamaki
Auckland New Zealand |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Anbhagan Ramaraju |
Delta Diabetic Centre |
D 125 10th Corss Thillai Nagar East
Tiruchirappalli
TAMIL NADU |
9538800755
dr.anbu87@gmail.com |
| Dr Utsa Basu |
Dr. Utsa Basu’s Clinic |
Department of General Medicine 65A middle Road Philips More 14 Entally Kolkata West Bengal 700014
Kolkata
WEST BENGAL |
9432658968
dr.utsabasu@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Avinash Institute of Craniofacial & Reconstructive Surgery |
Submittted/Under Review |
| Balaji 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
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Clever Sleep 1 |
3 capsules per day
Oral Dose
6 weeks |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Male |
| Details |
The person who met ICSD-3 insomnia criteria and determined the following through the CleverSleep SAS tool
Participants who are having moderate to severe insomnia
Patient must present with normal readings when tested for LFT and eGFR Creatinine levels and Blood Pressure
Participants who are willing to take CleverSleep Products for the entire duration of the study
Participants who are willing to complete all surveys
Participants who are willing to give samples for safety testing
|
|
| ExclusionCriteria |
| Details |
Any other sleep disorders
Excessive daytime sleepiness of unknown or untreated cause
Parasomnias (example sleepwalking night terrors) and sleep-related movement disorders such as restless legs syndrome (RLS)
Use of prescription sleep medications within the last 30 days
Use of medications included on the exclusion checklist provided
No psychiatric (including depression and anxiety) or neurological conditions
History of alcohol/substance abuse
Shift workers
Smokers
Diabetes (Type 1 and 2)
Major stress event in past 3 months
Deprivation index-ensuring socioeconomic consistency and in employment
Participants with a child under the age of 5 in the household will be excluded
Caregivers whose duties significantly disrupt nighttime sleep will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Overall improvement in sleep duration (change in Total sleep time (TST) from baseline
The reduction in sleep latency as the time taken to fall asleep, compared to baseline measurements
Improvement in sleep continuity (decrease in number of nighttime awakenings from baseline
Improvement in time taken to return to sleep after nighttime awakenings
Improvement in self-reported alertness 30 minutes after waking |
Week 00
Week 02
Week 04
Week 06
Week 08 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • If any adverse events (AE) or abnormal biological markers occur during period with their associated incidence and severity reported during the study period |
Week 00
Week 02
Week 04
Week 06
Week 08 |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/10/2025 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Primary End point - To evaluate the efficacy and safety of Naturopathic Sleeping Products in Male Patients with General Insomnia.
- Overall improvement in sleep duration, (change in Total sleep time (TST) from baseline.
- The reduction in sleep latency, as the time taken to fall asleep, compared to baseline measurements.
- Improvement in sleep continuity (decrease in number of nighttime awakenings from baseline).
- Improvement in time taken to return to sleep after nighttime awakenings
- Improvement in self-reported alertness 30 minutes after waking
Secondary Endpoint · To evaluate if any adverse events or abnormal biological markers occur and are associated with the use of the Naturopathic Sleeping Product throughout the study period. |