| 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 Lanka | |
| Public Title of Trial (in lay language) | 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 | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
Nil known | |
| Disease or Health Condition(s) studied | Chronic Kidney Disease (of unknown etiology | |
| 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 ? | |
| Study design | Single blinded randomized controlled trial | |
| 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 |
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| 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 |
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| Target number / sample size | 35 | |
| Primary outcome(s) | 1.Full blood count 2.Lipid profile 3.Renal profile 4.Liver enzymes-SGPT and SGOT 5.Urine full report including β2 globulin level 6.IFNδ 7.TNFα 8.HSP70 |
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| Primary outcome(s) - time of assessment(s) | 10 months | |
| Secondary outcome(s) | None | |
| Secondary outcome(s) - time of assessment(s) | None | |
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 25/04/2011 | |
| Anticipated end date | 25/01/2012 | |
| Recruitment status | Pending | |
| State of ethics review approval | Obtained from the Ethical Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka (14.12.2010) | |
| Funding source(s) | University Grants Commission - Sri Lanka | |
| Applicant's Email | jayasumanalk@yahoo.com | |
| Approval Status | Approved | |
| 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 0714393989 0252234464 jayasumanalk@yahoo.com |
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| Primary Study Sponsor/ Organization | Faculty of Medicine
University of Rajarata 0252234464 0252234462 www.rajaratauniversity.lk |
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| Contact Person for Public Queries | Dr. M.A.C.S.Jayasumana Lecturer in Pharmacology, Faculty of Medicine, Rajarata University Q2, FMAS, Saliyapura, Anuradhapura 0714393989 0252234462 jayasumanalk@yahoo.com |
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| Secondary Study Sponsor(s), (if any) | None |
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