Home » Trials » SLCTR/2011/005
Effects of Melothria maderaspatana (Titta kekiri) and Passiflora foetida (Dal batu) dry fruit preparation (topical application) on renal functions of Grade II and III Chronic Kidney Disease (of unknown etiology) patients in North central Province, Sri Lan
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SLCTR Registration Number
SLCTR/2011/005
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effects of Melothria maderaspatana (Titta kekiri) and Passiflora foetida (Dal batu) dry fruit preparation (topical application) on renal functions of Grade II and III Chronic Kidney Disease (of unknown etiology) patients in North central Province, Sri Lan
Public Title of Trial
Effects of Melothria maderaspatana (Titta kekiri) and Passiflora foetida (Dal batu) dry fruit preparation (topical application) on renal functions of Grade II and III Chronic Kidney Disease (of unknown etiology) patients in North central Province, Sri L
Disease or Health Condition(s) Studied
Chronic Kidney Disease (of unknown etiology)
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
None
What is the research question being addressed?
Can Melothria maderaspatana (Titta kekiri) and Passiflora foetida (Dal batu) dry fruit preparation (topical application) improve the renal functions of Grade II and III Chronic Kidney Disease (of unknown etiology) patients in North central province, Sri Lanka ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Paste of dried Melothria maderaspatana (Titta kekiri) and Passiflora foetida (Dal batu) will be applied for 6 hours daily to the big toe of test group for a period of 10 months. Placebo paste will be applied to the controls in a smiliar manner for the same period
Inclusion criteria
a)Diagnosed patients of having grade II and III CKDu, Normal HbA1C (?6.5%) and BP?160/100 mmHg untreated or ?140/90 mmHg on up to two antihypertensive agents, Persistent albuminuria + eGFR 30- 89 mi/min/1.73m2 b)Age between 20-60 years c)Permanent residents of Anuradhapura or Polonnaruwa district, for at least 5 years prior to diagnosis as Grade II or III CKDu
Exclusion criteria
a)Patients with no past history of or current treatment for diabetes mellitus or chronic and/or severe hypertension, snakebite, urological disease of known etiology or glomerulonephritis b)Patients who are suffering with other chronic diseases or on treatment for any other disease other than CKDu c)Patients aged less than 20 years and more than 65 years d)Pregnant and breast feeding mothers e)Patients who live outside the NCP,are not permanent resident within NCP at least 5 years prior to diagnose as CKDu and residents in GN divisions where WHO is conducting the Study for CKDu
Primary outcome(s)
|
1.
Full blood count |
[ 10 months ] |
|
2.
Lipid profile |
[ 10 months ] |
|
3.
Renal profile |
[ 10 months ] |
|
4.
Liver enzymes-SGPT and SGOT |
[ 10 months ] |
|
5.
Urine full report including β2 globulin level |
[ 10 months ] |
|
6.
IFNδ |
[ 10 months ] |
|
7.
TNFα |
[ 10 months ] |
|
8.
HSP70 |
[ 10 months ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
35
Countries of recruitment
Sri Lanka
Anticipated start date
2011-04-25
Anticipated end date
2012-01-25
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University Grants Commission - Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2010-12-14
Approval number
Not Available
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka. |
| Institutional Address: | 2nd Floor, Para-clinical Building Faculty of Medicine and Allied Sciences Rajarata University of Sri Lanka Saliyapura, Sri Lanka |
| Telephone: | +94 252053633 |
| Email: | ethicsreviewcommittee@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. M.A.C.S.Jayasumana
Lecturer in Pharmacology
Faculty of Medicine, Rajarata University
Q2, FMAS, Saliyapura, Anuradhapura
0252234464
0714393989
jayasumanalk@yahoo.com
Contact Person for Public Queries
Dr. M.A.C.S.Jayasumana
Lecturer in Pharmacology
Faculty of Medicine, Rajarata University
Q2, FMAS, Saliyapura, Anuradhapura
0252234464
0714393989
jayasumanalk@yahoo.com
Primary study sponsor/organization
Faculty of Medicine University of Rajarata
Q2, FMAS, Saliyapura, Anuradhapura
0252234464 0252234462
www.rajaratauniversity.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
