CTRI Number	CTRI/2019/11/022093 [Registered on: 21/11/2019] Trial Registered Retrospectively
Last Modified On:	16/11/2019
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Drug Ayurveda
Study Design	Randomized, Parallel Group Trial
Public Title of Study	Evaluation of Terminalia bellerica in preventing the progression of chronic kidney disease in patients with hyperuricemia.
Scientific Title of Study Modification(s)	Evaluation of Terminalia bellerica versus Febuxostat in preventing the progression of chronic kidney disease in patients with hyperuricemia - randomized double blind parallel group study.
Secondary IDs if Any Modification(s)	Secondary ID  Registry  CPT/CKD/01 version: 01 dated 02/07/2016  Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Dr K Niranjan  Address  Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad Hyderabad ANDHRA PRADESH 500082 India  Phone     Fax     Email  dr.niranjan22@gmail.com
Details Contact Person Scientific Query	Name  Dr P USHARANI  Address  Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad Hyderabad ANDHRA PRADESH 500082 India  Phone     Fax     Email  ushapingali@yahoo.com
Details Contact Person Public Query	Name  Dr P USHARANI  Address  Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad Hyderabad ANDHRA PRADESH 500082 India  Phone     Fax     Email  ushapingali@yahoo.com
Source of Monetary or Material Support	Nizams Institute of Medical Sciences
Primary Sponsor Modification(s)	Name  Dr K Niranjan  Address  Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad  Type of Sponsor  Other [Self]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study Modification(s)	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  Dr K Niranjan  Nizams Institute of Medical Sciences  Department of Clinical Pharmacology and Therapeutics, Nizams Institute of Medical Sciences, Panjagutta, Hyderabad Hyderabad   04023489021 dr.niranjan22@gmail.com
Details of Ethics Committee	No of Ethics Committees= 1   Name of Committee  Approval Status  NIMS institutional ethics committee  Approved
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied Modification(s)	Health Type  Condition  Patients  Chronic kidney disease, stage 3 (moderate)
Intervention / Comparator Agent	Type  Name  Details  Comparator Agent  Febuxostat 40 mg/day   Febuxostat–1 tablet of 40 mg(encapsulated in a similar capsule to that of Terminalia bellerica/placebo capsules) orally in the morning after food and an identical placebo capsule in the evening after food  Intervention  Terminalia bellerica 1000mg/day   1 capsule of 500mg Terminalia bellerica plus a similar placebo given orally twice a day after food (total dose of 1000mg/day Terminalia bellerica)  Intervention  Terminalia bellerica 2000mg/day   2 capsules of 500 mg given orally twice a day after food (total dose of 2000mg/day Terminalia bellerica)
Inclusion Criteria	Age From  18.00 Year(s) Age To  69.00 Year(s) Gender  Both  Details  1.Either gender, between the ages of 18 and 69 years. 2.Serum uric acid level ≥ 6.0 mg/dL and ≤ 12.0 mg/dL who are not on any hypouricemic agents or after having stopped all uric acid-lowering therapy for at least 2 months. 3.Serum creatinine ≥1.5mg/dl to ≤ 3.0 mg/dl. 4. Ability to comply with the requirements of the study and to give voluntary, written informed consent and willing to come for regular follow up visits.
ExclusionCriteria	Details  1.Presence of a gout flare during screening or baseline visit. 2.Patients currently using aspirin or other NSAIDS, diuretics, steroids, immunosuppressants, other medications with known urate-lowering effects. 3.History or presence of nephrolithiasis. 4.Patients who had undergone renal transplantation. 5.Known liver, thyroid or infectious diseases. 6.Uncontrolled hypertension or diabetes, severe hepatic impairment. 7.Known or suspected secondary hyperuricemia (e.g. due to myeloproliferative disorder, or organ transplant). 8.Chronic alcoholics and patients with history or suspicion of drug abuse. 9.Known hypersensitivity to any drugs or their constituents. 10.Pregnant or lactating females. 11.Patients currently on alternative system of medicine. 12.Participation within 30 days prior to screening in another investigational
Method of Generating Random Sequence	Computer generated randomization
Method of Concealment	On-site computer system
Blinding/Masking	Participant and Investigator Blinded
Primary Outcome	Outcome  TimePoints  1.Absolute change in serum creatinine and eGFR levels from baseline to the end of 24 weeks of treatment. 2.Mean percentage reduction in serum creatinine and eGFR levels from baseline to the end of 24 weeks of treatment.   0, 4, 8, 12, 16, 20, 24 weeks
Secondary Outcome	Outcome  TimePoints  1.Absolute change in serum uric acid levels from baseline to the end of 24 weeks of treatment. 2.Mean percentage reduction in serum uric acid levels from baseline to the end of 24 weeks of treatment.   0, 4, 8, 12, 16, 20, 24 weeks
Target Sample Size	Total Sample Size="60" Sample Size from India="60"
Phase of Trial	N/A
Date of First Enrollment (India)	24/08/2016
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="1" Months="6" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details Modification(s)	Not published
Brief Summary Modification(s)	Chronic kidney disease (CKD) has emerged as a global health problem of epidemic proportions. Although in many persons CKD remains an asymptomatic pathologic condition that progresses slowly, in others, it represents a progressive irreversible process that ultimately requires renal replacement therapy. Multiple studies have linked hyperuricemia with a greater risk of hypertension, metabolic syndrome, coronary artery disease, cerebrovascular disease, preeclampsia and kidney disease. Interventional studies suggest that decreasing uric acid levels in hyperuricemic patients with CKD is safe and might slow CKD progression. Xanthine oxidase inhibitors such as allopurinol or febuxostat are the preferred agents to decrease uric acid levels due to their effectiveness in both overproducers and undersecretors of uric acid.  Extracts from Terminalia bellerica are known to inhibit xanthine oxidase which is involved in the synthesis of uric acid. It was shown in an earlier study by us that Terminalia bellerica significantly decreased serum uric acid levels with no serious adverse effects. It was thus concluded that Terminalia bellerica has an excellent potential for treatment of hyperuricemia. So the current study was planned to evaluate the effect of Terminalia bellerica versus as Febuxostat in preventing the progression of chronic kidney disease in patients with hyperuricemia. Primary outcome measure was absolute change in serum creatinine and eGFR levels from baseline to the end of 24 weeks of treatment and mean percentage reduction in serum creatinine and eGFR levels from baseline to the end of 24 weeks of treatment. The study findings suggest that there was reduction in serum creatinine and eGFR in the treatment groups.