| CTRI Number |
CTRI/2024/03/063740 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of cancer related insomnia: A comparative study between melatonin and zolpidem |
|
Scientific Title of Study
|
Comparison of effectivity and adverse effects of two different doses of melatonin with zolpidem on insomnia in cancer patients: A prospective, comparative, interventional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SREEHARSH S |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR |
| Address |
DEPARTMENT OF PALLIATIVE MEDICINE
S.M.S MEDICAL COLLEGE, JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9447844714 |
| Fax |
|
| Email |
sreeharsh009@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR YOGENDRA SINGHAL |
| Designation |
PROFESSOR |
| Affiliation |
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR |
| Address |
DEPARTMENT OF PALLIATIVE MEDICINE
S.M.S MEDICAL COLLEGE, JAIPUR
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414850381 |
| Fax |
|
| Email |
singhalyogi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR YOGENDRA SINGHAL |
| Designation |
PROFESSOR |
| Affiliation |
SAWAI MAN SINGH MEDICAL COLLEGE AND ATTACHED HOSPITAL JAIPUR |
| Address |
DEPARTMENT OF PALLIATIVE MEDICINE
S.M.S MEDICAL COLLEGE, JAIPUR
RAJASTHAN
302004
India |
| Phone |
9414850381 |
| Fax |
|
| Email |
singhalyogi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical College and Attached Hospital, Jaipur Rajasthan. |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Sreeharsh S |
sawai man singh medical college jaipur, Rajastan |
DEPARTMENT OF PALLIATIVE MEDICINE ROOM NO;49, 4TH FLOOR DHANVANDARI BHAVAN
S.M.S HOSPITAL
Jaipur
RAJASTHAN |
9447844714
sreeharsh009@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE ETHICS COMMITTEE, S.M.S MEDICAL COLLEGE AND ATTACHED HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D499||Neoplasm of unspecified behavior of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1) MELATONIN 3mg
2) melatonin 5mg
3) ZOLPIDEM 5mg |
to compare the adverse effects and effectivity of zolpidem and melatonin
there will be 3 groups
1) melatonin 3mg
2) melatonin 5mg
3) zolpidem 5mg |
| Comparator Agent |
tablet melatonin and tablet zolpidem |
tablet melatonin 3 mg orally HS foe 6 weeks
tablet melatonin 5 mg HS orally for 6 weeks
tablet zolpidem 5 mg HS orally for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age between 20 and 65 years
Registered in Palliative Medicine Department
Suffering from a histologically diagnosed cancer
Patients with sleep disturbance with a score 5 or higher on Pittsburgh sleep quality index (PSQI)
Patient giving written informed consent for this study
Patient having adequate pain relief and no history of dyspnoea
|
|
| ExclusionCriteria |
| Details |
Patients with previous psychiatric disorder
Patients on any sedatives/ hypnotics
Patients in anti-anxiety medications
Patient on anti-psychiatric treatment
Patient having language and communication difficulties
Patients using any kind of sleeping aids
Having used melatonin for last one month
Pregnant and lactating women
Patients having severe liver and renal dysfunction Â
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in Pittsburgh sleep quality index score
|
baseline,2,4 and 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in Hospital Anxiety Depression Score
|
2 weeks
4 weeks
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 4 |
|
Date of First Enrollment (India)
|
15/03/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Cancer patients with insomnia are identified with PSQI score > 5 HADS also measured at bseline. patients are randomized into 3 groups getting melatonin 3mg , melatonin 5mg, and zolpidem 5mg and assessed at 2 weeks, 4 weeks and 6 weeks PSQI and HADS measured |