| CTRI Number |
CTRI/2024/07/069863 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of melatonin ( a hormone for sleep induction)
supplement on the quality of sleep and control of blood pressure in hemodialysis patients |
|
Scientific Title of Study
|
Study of Oral Melatonin on Sleep quality and Blood pressure in Maintenance Hemodialysis patients |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakthirajan R |
| Designation |
Associate Professor |
| Affiliation |
Madras Medical College |
| Address |
Room no 208, Second Floor,
Institute of Nephrology,
Rajiv Gandhi Government General Hospital,
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9444126080 |
| Fax |
|
| Email |
draatral@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakthirajan R |
| Designation |
Associate Professor |
| Affiliation |
Madras Medical College |
| Address |
Institute of Nephrology,
Madras Medical College,
Rajiv Gandhi Government General Hospital, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9444126080 |
| Fax |
|
| Email |
draatral@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sakthirajan R |
| Designation |
Associate Professor |
| Affiliation |
Madras Medical College |
| Address |
Institute of Nephrology,
Madras Medical College,
Rajiv Gandhi Government General Hospital, Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9444126080 |
| Fax |
|
| Email |
draatral@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madras Medical College,
Chennai 600003
India |
|
|
Primary Sponsor
|
| Name |
Madras Medical College |
| Address |
Institute of Nephrology, Rajiv Gandhi Government General Hospital, Chennai 600003 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sumathi G |
Madras Medical College And Rajiv Gandhi Government General Hospital |
Room no 208, Second Floor,
Institute of Nephrology
Chennai
TAMIL NADU |
9486306420
sumathi.krenos@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Madras Medical College, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Oral melatonin supplementation |
Oral melatonin supplementation
3 mg dosage once daily at bedtime for a study period of 3 months to maintenance hemodialysis patients with sleep disturbances and to study their effect of Blood pressure and sleep quality |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Maintenance hemodialysis patients who are more than 18 years
2. Dialysis vintage more than one year
3. Baseline Pittsburgh Sleep Quality Index more than 5 |
|
| ExclusionCriteria |
| Details |
Less than 18 years, more than 65 years, with advanced liver disease, malignancy, heart failure, active infection, pregnancy, BMI more than 40, psychosis, patient on hypnotics |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of oral melatonin on sleep quality, 24 hour ambulatory BP and depression scoring in maintenance hemodialysis patients |
3 months after oral melatonin supplementation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of oral melatonin on depression scoring |
3 months supplementation |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2 |
|
Date of First Enrollment (India)
|
11/07/2024 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sumathi.krenos@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Patients with end stage kidney disease on hemodialysis commonly have sleep disturbances. Sleep disturbances have effect on blood pressure of the individuals. Benzodiazepines used to treat insomnia in maintenance hemodialysis patients have many adverse effects like drug dependence, light headedness and unsteadiness. Non benzodiapine drugs like melatonin can be used in the patients so as to avoid these side effects and also they have an effect on lowering blood pressure of the individuals. So,we are doing a single arm trial in maintenance hemodialysis patients more than 18 years with sleep disturbances with oral melatonin supplementation 5mg, so as to prove their beneficial effect on sleep disturbances and lowering BP. |