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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2011/005 |
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Date of registration:
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25/03/2011 |
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Primary sponsor: |
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Public title:
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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 Lanka
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Scientific title:
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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 Lanka |
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Date of first enrolment:
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25/4/2011 |
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Target sample size:
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35 |
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Recruitment status: |
Pending |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={9105D768-4383-4330-B318-EF490933BF26} |
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Study type:
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Interventional |
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Study design:
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Single blinded randomized controlled trial
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Dr. M.A.C.S.Jayasumana
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Address:
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Q2, FMAS, Saliyapura, Anuradhapura
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Telephone:
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0714393989 |
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Email:
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jayasumanalk@yahoo.com |
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Affiliation:
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Lecturer in Pharmacology, Faculty of Medicine, Rajarata University |
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Name:
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Dr. M.A.C.S.Jayasumana
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Address:
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Q2, FMAS, Saliyapura, Anuradhapura
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Telephone:
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0714393989 |
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Email:
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jayasumanalk@yahoo.com |
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Affiliation:
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Lecturer in Pharmacology, Faculty of Medicine, Rajarata University |
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Key inclusion & exclusion criteria
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Inclusion criteria: a)Diagnosed patients of having grade II and III CKDu, Normal HbA1C (and#706;6.5%) and BPand#706;160/100 mmHg untreated or and#706;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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Chronic Kidney Disease (of unknown etiology
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Intervention(s)
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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
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Primary Outcome(s)
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1.Full blood count
2.Lipid profile
3.Renal profile
4.Liver enzymes-SGPT and SGOT
5.Urine full report including and#946;2 globulin level
6.IFNand#948;
7.TNFand#945;
8.HSP70
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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University Grants Commission - Sri Lanka
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