Herbal Preparation Used as Adjuvant Therapy on Diabetic Ulcers
NCT ID: NCT00393510
Last Updated: 2010-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
2000-11-30
2006-03-31
Brief Summary
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Objective:To determine whether a course of herbal preparation used as an adjuvant therapy for diabetic patients suffering from chronic foot ulcers may promote healing so that major leg amputation can be avoided.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Traditional Chinese Medicine
12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
TCM
The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
The formula consisted of 12 herbs, viz:
Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae
Placebo
Placebo was made with starch and colouring materials. Given to patient orally twice a day
Placebo
Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
The placebo was made with starch and colouring materials.
Interventions
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TCM
The Decoction is taken orally, twice a day, treatment period is 24 weeks The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
The formula consisted of 12 herbs, viz:
Radix astragali, Rhizoma atractylodis marcocephalae, Radix stephaniae tetrandrae, Radix polygoni multiflori, Radix rehmanniae, Radix smilax china, Fructus corni, Rhizoma dioscoreae, Cortex moutan, Rhizoma alismatis, Rhizoma smilacis glabrae, and Fructus schisandrae
Placebo
Placebo taking orally, twice a day, 24 week treatment period The herbal formulation or a placebo was given as an adjuvant therapy for the treatment of the unhealing ulcers in these diabetic patients.
The placebo was made with starch and colouring materials.
Eligibility Criteria
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Inclusion Criteria
* Presence of gangrene or non-healing ulcer in diabetic patients over the foot or feet. Infection should be well controlled.
* Good glycaemic control
Exclusion Criteria
* Patients taking digitalis glycosides
* Patients with abnormal liver function tests
* Patients with plasma creatinine great then 150 umol/l or unstable renal function
* Poorly controlled Diabetes Mellitus
* Uncontrolled infection
* History of adverse reaction to herbal medicine
* Unstable medical conditions
* Non-compliance with regime
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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The Institute of Chinese Medicine, CUHK
Principal Investigators
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Leung Ping Chung, MD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Orthopaedics & Traumatology, CUHK
Locations
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Department of Orthopaedics & Traumatology, Prince of Wales hospital
Hong Kong, , China
Department of Orthopaedics and Traumatology, Kwong Wah Hospital
Hong Kong, , China
Countries
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References
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Levin ME. Diabetic foot ulcers: pathogenesis and management. J ET Nurs. 1993 Sep-Oct;20(5):191-8.
Nelzen O, Bergqvist D, Lindhagen A. High prevalence of diabetes in chronic leg ulcer patients: a cross-sectional population study. Diabet Med. 1993 May;10(4):345-50. doi: 10.1111/j.1464-5491.1993.tb00077.x.
Steed DL, Goslen JB, Holloway GA, Malone JM, Bunt TJ, Webster MW. Randomized prospective double-blind trial in healing chronic diabetic foot ulcers. CT-102 activated platelet supernatant, topical versus placebo. Diabetes Care. 1992 Nov;15(11):1598-604. doi: 10.2337/diacare.15.11.1598.
Ahlgren SC, Levine JD. Protein kinase C inhibitors decrease hyperalgesia and C-fiber hyperexcitability in the streptozotocin-diabetic rat. J Neurophysiol. 1994 Aug;72(2):684-92. doi: 10.1152/jn.1994.72.2.684.
Bazan NG, Gordon WC, Marcheselli VL, Lukiw WJ, Duhault J, Koenig-Berard E, Linn DM, DeCoster MA, Mukherjee PK. Experimental models and their use in studies of diabetic retinal microangiopathy. Therapie. 1997 Sep-Oct;52(5):447-51.
Diemel LT, Brewster WJ, Fernyhough P, Tomlinson DR. Expression of neuropeptides in experimental diabetes; effects of treatment with nerve growth factor or brain-derived neurotrophic factor. Brain Res Mol Brain Res. 1994 Jan;21(1-2):171-5. doi: 10.1016/0169-328x(94)90391-3.
Follansbee MH, Beyer KH Jr, Griffith JW, Vesell ES. Studies on pyrazinoylguanidine. 5. Temporal effects over 24 weeks demonstrating attenuation of diabetic nephropathy in STZ-diabetic rats. Pharmacology. 1997 May;54(5):241-55. doi: 10.1159/000139492.
Kunjathoor VV, Wilson DL, LeBoeuf RC. Increased atherosclerosis in streptozotocin-induced diabetic mice. J Clin Invest. 1996 Apr 1;97(7):1767-73. doi: 10.1172/JCI118604.
Liu S, Barac-Nieto M. Renal protein degradation in streptozotocin diabetic mice. Diabetes Res Clin Pract. 1997 Jan;34(3):143-8. doi: 10.1016/s0168-8227(96)01353-8.
Mavrikakis ME, Sfikakis PP, Kontoyannis D, Horti M, Kittas C, Koutras DA, Raptis SA. Macrovascular disease of coronaries and cerebral arteries in streptozotocin-induced diabetic rats. A controlled, comparative study. Exp Clin Endocrinol Diabetes. 1998;106(1):35-40. doi: 10.1055/s-0029-1211947.
Zochodne DW, Murray MM, van der Sloot P, Riopelle RJ. Distal tibial mononeuropathy in diabetic and nondiabetic rats reared on wire cages: an experimental entrapment neuropathy. Brain Res. 1995 Nov 6;698(1-2):130-6. doi: 10.1016/0006-8993(95)00876-r.
Wagner EW. Classification of neuropathic foot problems AAOS instructional lecture 28 St. Louis Mosby 1979 p143-165
Brodsky JW. Diabetic Foot Surgery of Foot and Ankle. St. louis Mosby 1992, p1361-1467
Conn, H.M., M.A. and Emmel, V.M. Staining Procedures. Williams and Wilkins Co., Baltimore, 289 pp.m (1960)
Professor P.C. Leung. Limb Salvage for Diabetic ulceration with Traditional Chinese Techniques. Pacific, BioTech News. Vol.1 No.31 1998, Singapore
J.Y.Shi, Collected publications on the applicatioin of Shi's regime for the treatment of diabetic ulcers (in Chinese) special publicaiton on Diabetic Ulcer. Shanghai Research Institute on TCM.
Leung PC, Pang SY, Wong EL, Cheng KF. Inflammatory state of type II diabetic patients with chronic ulcers in response to herbal treatment. Foot (Edinb). 2012 Sep;22(3):181-5. doi: 10.1016/j.foot.2012.03.001. Epub 2012 Mar 30.
Other Identifiers
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CRE-8342
Identifier Type: -
Identifier Source: org_study_id
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