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Trial registered on ANZCTR


Registration number
ACTRN12618000001291
Ethics application status
Approved
Date submitted
9/09/2017
Date registered
8/01/2018
Date last updated
11/02/2019
Date data sharing statement initially provided
11/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomized control trial for effectiveness of Zolpidem versus acupressure on sleep in hemodialysis patients having chronic kidney disease (CKD) associated pruritus
Scientific title
Randomized control trial for effectiveness of Zolpidem versus acupressure on sleep quality in hemodialysis patients having chronic kidney disease (CKD) associated pruritus
Secondary ID [1] 292842 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Sleep quality 304685 0
CKD associated pruritus 304686 0
Chronic Kidney disease 305052 0
hemodialysis 305053 0
Condition category
Condition code
Renal and Urogenital 303997 303997 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be randomized 1:1 into two group in which one group patients will receive Zolpidem (oral tablet) 10 mg once daily and other group will receive acupressure therapy on acupressure points KI-1 points in both foots. The acupressure therapy will be delivered daily for 8 weeks. The therapy will be applied at acupoint KI-1 (Yongquan) in total 6 minutes with 3 minutes per foot and the applied intensity will be adjusted per patient’s level of tolerance for 8 weeks at North west General Hospital and Research Center Peshawar Pakistan and Institute of Kidney diseases Peshawar. At week 4 and week 8 from the baseline the participants in both groups control and intervention group will be required to fill the PSQI questionnaire to assess improvement in sleep quality and improvement in PSQI score and improvement in quality of life impaired due to poor sleep by EQ5D 3L. Naranjo’s algorithm known to be a valid measure for reporting and authenticating drug-related events will be required to fill All the patients completing 6 weeks of Zolpidem therapy and acupressure therapy will be questioned about any adverse events that they may have experienced after taking Zolpidem (oral tablet) 10 mg once daily. The information will be collected based on the patients experience and the list of the adverse events.
Intervention code [1] 299089 0
Treatment: Other
Intervention code [2] 300564 0
Treatment: Drugs
Comparator / control treatment
The participants will receive acupressure therapy on acupoint KI-1 points in foot. The acupressure therapy will be delivered daily for 8 weeks. The therapy will be applied at acupoint KI-1 (Yongquan) in total 6 minutes with 3 minutes per foot and the applied intensity will be adjusted per patient’s level of tolerance. The duration of the intervention: daily for 8 weeks at North west General Hospital and Research Center Peshawar Pakistan and Institute of Kidney diseases Peshawar. At week 4 and week 8 from the baseline the participants in both groups control and intervention group will be required to fill the PSQI questionnaire to assess improvement in sleep quality and improvement in PSQI score and improvement in quality of life impaired due to poor sleep by EQ5D 3L.
Control group
Active

Outcomes
Primary outcome [1] 303329 0
Sleep quality assessed by Pittsburgh Sleep Quality Index (PSQI) scores among patients having chronic kidney disease associated pruritus
Timepoint [1] 303329 0
At baseline (0 week) , 4 weeks and 8 weeks (primary time point).
Secondary outcome [1] 338658 0
Patient acceptability to be assessed by "Treatment Acceptability Questionnaire (TAQ)".
Timepoint [1] 338658 0
At baseline (0 week) , 4 weeks and 8 weeks (time point).
Secondary outcome [2] 344118 0
Quality of life (EQ5D-3L) will be measured.
Timepoint [2] 344118 0
At 6th weeks and 8th weeks (time point).
Secondary outcome [3] 344119 0
Adverse events will be monitored by Naranjo’s algorithm known to be a valid measure for reporting and authenticating drug-related events.
Timepoint [3] 344119 0
At 6th weeks and 8th weeks (time point).

Eligibility
Key inclusion criteria
Participants for this RCT must be Adult patients (above age of 18 years), diagnosed with end-stage kidney disease; having CKD associated pruritus affecting sleep quality; and receiving dialysis twice or thrice weekly.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants not having CKD associated pruritus, PSQI score less than 5, using any treatment to improve sleep, no willing to participate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
To ensure adequate concealment of allocation, the patients handpick a numbered envelope from the basket.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The participants will be randomized into two groups i.e. sham acupressure and acupressure by simple random technique will be used form a list of random numbers of eligible patients which will be compiled by using the patients’ hospital identification numbers. After recruitment, the patients will be requested to handpick an envelope from the basket indicating allocation to either control or intervention group with 1:1 randomization.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Single-blind trial where participants will not be aware whether they are receiving acupressure treatments. This information will only be known to the therapist delivering therapy and the investigator who will not disclose this information to the participants or other study investigators or outcome assessors.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed by using SPSS 22. Baseline characteristics will be expressed as frequencies (percentages) for categorical variables, mean ± SD for continuous normally distributed variables, and median (interquartile range) for continuous non-normally distributed variables. PSQI global scores will be analyzed using Analysis of covariance (ANCOVA) to examine the differences in treatment effects between the intervention and control groups

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/03/2018
Actual
8/03/2018
Date of last participant enrolment
Anticipated
Actual
31/03/2018
Date of last data collection
Anticipated
Actual
31/05/2018
Sample size
Target
58
Accrual to date
Final
58
Recruitment outside Australia
Country [1] 9186 0
Pakistan
State/province [1] 9186 0
Khyber Pukhtoonkhwa

Funding & Sponsors
Funding source category [1] 297475 0
University
Name [1] 297475 0
Monash University Malaysia
Country [1] 297475 0
Malaysia
Primary sponsor type
University
Name
Monash University Malaysia
Address
Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, MALAYSIA
Country
Malaysia
Secondary sponsor category [1] 296769 0
Hospital
Name [1] 296769 0
North West General Hospital and Research Center Peshawar Pakistan
Address [1] 296769 0
Sector A-3, Phase- 5, 25000, Hayatabad,Peshawar-Pakistan
Country [1] 296769 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298578 0
North West General Hospital and Resarch center Peshawar Pakistan
Ethics committee address [1] 298578 0
Ethics committee country [1] 298578 0
Pakistan
Date submitted for ethics approval [1] 298578 0
10/08/2017
Approval date [1] 298578 0
07/09/2017
Ethics approval number [1] 298578 0
NwGH/Res/2257

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2031 2031 0 0
/AnzctrAttachments/373620-NWGH ethics approval.pdf (Ethics approval)
Attachments [2] 2032 2032 0 0
/AnzctrAttachments/373620-Consent Form English.pdf (Participant information/consent)
Attachments [3] 2033 2033 0 0
/AnzctrAttachments/373620-Consent form Urdu-1.pdf (Participant information/consent)
Attachments [4] 2034 2034 0 0
/AnzctrAttachments/373620-Research Project Explanatory Statement English.pdf (Participant information/consent)
Attachments [5] 2035 2035 0 0
/AnzctrAttachments/373620-Survey Explanatory Statement URDU - Copy-1.pdf (Participant information/consent)

Contacts
Principal investigator
Name 77538 0
Dr Tahir Mehmood Khan
Address 77538 0
School of Pharmacy, Monash University Malaysia,
Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Country 77538 0
Malaysia
Phone 77538 0
+603 5514 6364
Fax 77538 0
+603 5514 6364
Email 77538 0
tahir.mehmood@monash.edu
Contact person for public queries
Name 77539 0
Inayat Ur Rehman
Address 77539 0
PhD Scholar, School of Pharmacy, Monash University Malaysia
Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Country 77539 0
Malaysia
Phone 77539 0
+60173485414
Fax 77539 0
Email 77539 0
inayat.rehman@monash.edu
Contact person for scientific queries
Name 77540 0
Tahir Mehmood Khan
Address 77540 0
Senior Lecturer, School of Pharmacy, Monash University Malaysia
Jalan Lagoon Selatan, 47500 Bandar Sunway, Selangor Darul Ehsan, Malaysia
Country 77540 0
Malaysia
Phone 77540 0
+601127640646
Fax 77540 0
Email 77540 0
tahir.mehmood@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
anyone who wishes to access it
How or where can data be obtained?
Access subject to approvals by Principal Investigator, requirement to sign data access agreement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.