| CTRI Number |
CTRI/2025/09/095214 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| 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 Women Experiencing Sleep Disturbances Due To The Impact Of Menopause |
|
Scientific Title of Study
|
A Single-Arm Single Blind Multicenter Interventional Study To Evaluate The Efficacy And Safety Of Naturopathic Sleeping Products in Peri/Menopause Women Experiencing Sleep Disturbances Due To The Impact Of Menopause |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SLS-CT-0009-25-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 |
D 125 10th Cross Street 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 |
D 125 10th Cross Street 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 |
D 125 10th Cross Street Thillai Nagar East
TAMIL NADU
620018
India |
| Phone |
9538800755 |
| Fax |
|
| Email |
dr.anbu87@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sleep Drops International
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
Modification(s)
|
| Name |
Address |
| Spinos Life Science and Research Private limited |
Door No 29 A Krishna Madura Vanam Alankar Thottam Vellakinar Pirivu Thudiyalur Coimbatore Tamil Nadu 641029 |
|
|
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 |
Department of Psychiatry
D 125 10th Cross Street 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 and 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
Clever Sleep 2
Clever Sleep 3 |
3 Capsules per day
2 ml per day
4 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 |
Female |
| Details |
The person who met ICSD-3 insomnia criteria met and determined through 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
Willing to take CleverSleep Products for the entire duration of the study
Experiencing Hot flushes as noted in question 1 on the MISS with an impact and symptom score of 4 or greater
Experiencing Night Sweats as noted in question 2 on the MISS with an impact and symptom score of 4 or greater
Experiencing Sleep disturbances as noted in question 3 on the MISS with an impact and symptom score of 4 or greater
Experiencing an average Pain score of 4 or greater on the CleverlSleep Adapted Numeric Pain Scale
Experiencing Pain as noted in question 10 on the MISS with an impact and symptom score of 4 or greater
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 (e.g., 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 (Annexure VIII)
No psychiatric (including depression and anxiety) or neurological conditions
Pregnant or breastfeeding women will be excluded
History of alcohol/substance abuse
Shift workers
Smokers
Major stress event in past 03 months
Deprivation index-ensuring socioeconomic consistency and in employment
Participants with a child under the age of 5 in the household will be excluded
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in TST (total sleep time) from baseline
Improvement in sleep latency (time to get to sleep)
Decrease in night time awakenings
Improvement in time to get back to sleep if woken
Improvement in how alert 30 minutes after waking
Pain reduction (using CS Adapted NPS and MISS Question 10 to establish a reduction in impact and scores)
MISS Questionnaire
Hot flushes/night sweats impact scores reduction (using MISS Questions 1 and 2)
Insomnia improvement (using MISS Question 3)
Improvement in Quality of Life and other menopausal symptoms (using MISS tool impact scores)
|
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 the study period with their associated incidence and severity |
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) |
15/01/2026 |
| 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
|
| The investigational treatment will be administered for a planned duration of 06 weeks. If the Investigator determines that continued use of the product may offer further benefit to the participant, treatment may be extended beyond 06 weeks at the Investigator’s discretion, based on clinical judgment and participant response. Treatment will be discontinued in the event of withdrawal of consent or if any adverse effect occurs that warrants discontinuation.. *Visit 1 is the day of signing the consent. Enrollment / screening / Baseline is conducted for the first 02 weeks and then treatment will start if patient still meets the criteria. |
|