Effectiveness and safety of Xuefu Zhuyu oral liquid (血府逐瘀口服液) on Qi-stagnation and blood-stasis pattern in patients with stable angina, tension-type headache and primary dysmenorrhea: rationale and design of a master protocol

doi:10.19852/j.cnki.jtcm.20230517.001

Abstract

Abstract:

We present the rationale and design of a master protocol study that clarifies the effectiveness and safety of Chinese herbal formulas on Qi-stagnation and blood-stasis pattern (QBP). Three randomized controlled trials (RCTs) and real-world observational studies. Based on three registry cohorts of stable angina, tension-type headache and primary dysmenorrhea, patients with QBP will be enrolled in RCTs to receive either Xuefu Zhuyu (血府逐瘀, XFZY) oral liquid or a placebo, while patients with non-QBP will be enrolled in the observational studies and experience follow-up. 1414 patients (RCTs: 574; observational studies: 840) will be recruited at seven centers in China over a 3-year period. The primary outcome is the visual analog scale of pain intensity. Adverse events will also be reported. The analysis will be undertaken separately in each sub-study, and then an overall analysis combining multiple subgroups will be performed to comprehensively investigate the effect of XFZY oral liquid. This study will provide high-quality evidence of XFZY oral liquid for QBP patients and show a paradigm of post-marketing evaluation of the effectiveness and safety for Chinese medicine following the notion of the pattern dominating different disease research models.

Key words: angina, stable, tension-type headache, primary dysmenorrhea, Chinese herbal formula, Chinese medicine pattern, master protocol

CAO Wencong, LIAO Shaojun, ZHANG Yuanwen, ZHOU Li, LI Geng, OUYANG Wenwei, WEN Zehuai. Effectiveness and safety of Xuefu Zhuyu oral liquid (血府逐瘀口服液) on Qi-stagnation and blood-stasis pattern in patients with stable angina, tension-type headache and primary dysmenorrhea: rationale and design of a master protocol[J]. Journal of Traditional Chinese Medicine, 2023, 43(4): 815-823.

Figures/Tables 3

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Symptoms and signs	Yes	No	Score
Pain^a	9	0	-
Irritability/depression	16	0	-
Distending pain	2	0	-
Scurry pain	6	0	-
Chest distress	0.5	0	-
Lumps in body	7	0	-
Petechia in the tongue	4	0	-
Purplish tongue	1	0	-
Uneven pulse	4	0	-
Deep pulse	2	0	-
If the sum score ≥20, QBP can be diagnosed.		Score:	-

Symptoms and signs	Yes	No	Score
Pain^a	9	0	-
Irritability/depression	16	0	-
Distending pain	2	0	-
Scurry pain	6	0	-
Chest distress	0.5	0	-
Lumps in body	7	0	-
Petechia in the tongue	4	0	-
Purplish tongue	1	0	-
Uneven pulse	4	0	-
Deep pulse	2	0	-
If the sum score ≥20, QBP can be diagnosed.		Score:	-

Disease	Experimental group	Control group	Follow-up
SA	Routine care + XFZY oral liquid, 20 mL each dose, three times per day, for 12 weeks	Routine care^a+ placebo, 20 mL each dose, three times per day, for 12 weeks	12-week follow-up
TTH	XFZY oral liquid, 20 mL each dose, three times per day, for 4 weeks	Placebo, 20 mL each dose, three times per day, for 4 weeks	8-week follow-up
PD	XFZY oral liquid, 20 mL each dose, three times per day, for 3 menstrual cycles (about 12 weeks)	Placebo, 20 mL each dose, three times per day, for 3 menstrual cycles (about 12 weeks)	12-week follow-up

Disease	Experimental group	Control group	Follow-up
SA	Routine care + XFZY oral liquid, 20 mL each dose, three times per day, for 12 weeks	Routine care^a+ placebo, 20 mL each dose, three times per day, for 12 weeks	12-week follow-up
TTH	XFZY oral liquid, 20 mL each dose, three times per day, for 4 weeks	Placebo, 20 mL each dose, three times per day, for 4 weeks	8-week follow-up
PD	XFZY oral liquid, 20 mL each dose, three times per day, for 3 menstrual cycles (about 12 weeks)	Placebo, 20 mL each dose, three times per day, for 3 menstrual cycles (about 12 weeks)	12-week follow-up

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