NCT03608917

Efficacy and Safety of Total Glucosides of Paeony Combined With NB-UVB on Treating Vitiligo

Efficacy and Safety of Total Glucosides of Paeony Combined With NB-UVB in the Treatment of Sporadic Vitiligo in Proceeding: a Double-blind, Randomized, Placebo-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: xjpfW · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

1. Total Glucosides of Paeony(TGP) As a traditional Chinese medicine, peony root is the dried root of peony of Ranunculaceae, cultivated all over the country.The main ingredient is a group of glycosides, including paeoniflorin, hydroxy paeoniflorin, paeoniflorin, paeoniflorin, benzoyl paeoniflorin etc, collectively referred to as total glucosides of paeony（TGP）. Paeoniflorin accounted for more than 90% of the TGP, is the main active ingredient of white peony root.By pharmacological and clinical studies of TGP, it have found that the mechanism of TGP is unique and mainly acts on the upstream of the immune response - inhibiting the presentation of antigens. It is different from immunosuppressive agents on T, B lymphocytes, or hormones and other drugs acting on the whole process. 2. Vitiligo Vitiligo is a pigment deprived skin disease caused by the destruction of melanocytes, the global incidence of about 1%. The pathogenesis is not yet clear, the current study shows that oxidative stress and autoimmunity is an important part of its occurrence and development. 3. The basic and clinical research of TGP used in vitiligo The ratio of cluster of differentiation 4+ / cluster designation 8+ T cell vs. cluster of differentiation 4+ chronotropic dose 25+ in the peripheral blood of patients with vitiligo could be significantly increase, after patients treatment by TGP combined with tacrolimus. Thereby enhancing the patient's maintenance of immune self-stability and Immune tolerance ability, promoting the healing of skin lesions. It showed significant effect in stable vitiligo,when patients treated by autologous epidermal grafting combined with TGP.

Conditions

• Vitiligo

Interventions

Type	Name	Description
DRUG	Total Glucosides of Paeony(TGP)	Total Glucosides of Paeony(TGP) as a traditional Chinese medicine, peony root is the dried root of peony of Ranunculaceae, cultivated all over the country.TGP is new drug of western medicine, original discovered by Professor Xu who is a famous pharmacologist. The main ingredient is a group of glycosides, including paeoniflorin, hydroxy paeoniflorin, paeoniflorin, paeoniflorin, benzoyl paeoniflorin etc, collectively referred to as total glucosides of paeony（TGP）
DEVICE	Narrow band-ultraviolet b（NB-UVB）	phototherapy on treating vitiligo
DRUG	Total Glucosides of Paeony(TGP) analogue	Total Glucosides of Paeony(TGP) analogue as a placebo for Control group

Timeline

• Start date: 2018-04-17
• Primary completion: 2019-04-30
• Completion: 2019-07-31
• First posted: 2018-08-01
• Last updated: 2021-03-11

Locations

1 site across 1 country: China