Wangjing Hospital, China Academy of Chinese Medical Sciences
The purpose of this study is to evaluate the efficacy and possible mechanism of traditional Chinese medicine in the treatment of primary osteoporosis (Kidney Yang Deficiency Syndrome).It is a randomized, placebo-controlled trial.
Primary Osteoporosis
Caltrate D
Chinese medicine prescription
Placebo
Not Applicable
The subjects are selected according to the inclusion criteria and exclusion criteria. Using the network random system, 120 subjects who meet the research criteria are randomly divided into control group and experimental group, with 60 cases in each group. Patients in treatment group take the granule of traditional Chinese medicine prescription, while the control group take simulate granule of the prescription. Both two groups are under symptomatic treatment. Twice a day, in the morning and evening, 30 minutes after meals.The experimental drugs were provided by the pharmacy department of Wangjing hospital, Chinese Academy of traditional Chinese medicine, and the course of treatment was 3 months.The observation time points were before treatment, 2 weeks after treatment, 1 month after treatment and 3 months after treatment. Visual Analogue Score (VAS), Traditional Chinese Medicine(TCM)syndrome score, SF-12 scale and bone metabolism index were used as observation indexes.At the same time, it is planned to determine EphrinB2, EphB4, Runx2 and VEGF in serum by ELISA. Tele-medicine and information management system is established to help achieve follow-up interviews.Random numbers are generated by SAS 9.4 software. The subjects, caregivers, investigators and outcomes assessors in this study are all blinded.}}
Study Type : | Interventional |
Estimated Enrollment : | 120 participants |
Masking : | Quadruple |
Primary Purpose : | Treatment |
Official Title : | Clinical Study of Bugu Shengsui Decoction for the Treatment of Primary Osteoporosis (Kidney Yang Deficiency Syndrome) |
Actual Study Start Date : | July 1, 2022 |
Estimated Primary Completion Date : | December 1, 2022 |
Estimated Study Completion Date : | May 1, 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Traditional Chinese medicine On the basis of general symptomatic treatment of caltrate D,patients in experimental group use the traditional Chinese medicine application prescription. |
Drug: Caltrate D Drug: Chinese medicine prescription |
Placebo Comparator: Comparator: placebo On the basis of general symptomatic treatment of caltrate D,patients in placebo group use the simulate granule of traditional Chinese medicine application prescription. |
Drug: Caltrate D Drug: Placebo |
Ages Eligible for Study: | 45 Years to 80 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Wangjing Hospital of China Academy of Chinese Medical Sciences
Beijing, China,