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Open Access Original Article Issue
Efficacy and safety of Lutai Danshen Baishao granules for treating female melasma: A randomized, double-blind, placebo-controlled trial
Journal of Traditional Chinese Medical Sciences 2025, 12(1): 71-78
Published: 07 December 2024
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Objective

To investigate the potential efficacy and safety of Lutai Danshen Baishao granules (LDBG) for treating female melasma associated with kidney deficiency and blood stasis patterns.

Methods

A randomized, double-blind, placebo-controlled trial was conducted at the Third Central Hospital of Tianjin, China from March to December 2023. A total of 110 female patients with melasma linked to kidney deficiency and blood stasis were enrolled and treated with either LDBG or a placebo twice daily for 60 days. Efficacy was assessed through measures such as the total melasma area, reduced melasma area, reduction rate of melasma area, melasma color score, Melasma Area and Severity Index (MASI) score, and traditional Chinese medicine (TCM) symptom score scale. Safety assessments included routine blood and biochemical tests.

Results

Participants in both groups were aged 52–63 years, with no significant differences. After the 2-month intervention, the total melasma area decreased in both groups; however, a greater reduction was observed in the test group [462.50 mm2 (12.81%) vs. 100.00 mm2 (3.11%), P <.001]. Moreover, LDBG treatment significantly reduced the MASI and melasma color scores in the test group (P <.05). The total TCM symptom evaluation score significantly decreased (test group:6.00 vs. placebo group:7.00, P =.001), with significant relief in symptoms such as improvement in dark lips, nails, and waist soreness in the test group, compared with that in the placebo group (P <.05). Within-group comparisons revealed that TCM syndrome was significantly alleviated in the test group (P <.05).

Conclusion

LDBG intervention shows promising effectiveness in reducing female melasma and alleviating TCM syndromes.

Open Access Original Article Issue
Efficacy and safety of Liqingtong granules in the treatment of hyperuricemia: A randomized double-blind placebo-controlled pilot clinical trial
Journal of Traditional Chinese Medical Sciences 2024, 11(4): 415-422
Published: 19 September 2024
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Objective

To investigate the efficacy and safety of Liqingtong (LQT) granules in patients with dampness-heat hyperuricemia.

Methods

A randomized, double-blind, placebo-controlled pilot trial was conducted at the 983rd Hospital of the Joint Logistic Support Force of the People's Liberation Army from March 15, 2023, to August 10, 2023. In total, 119 participants were enrolled in this trial, and participants were given either LQT granules or placebo for 60 days based on a health education. The primary outcome was serum uric acid (SUA) level, and the secondary outcome was the traditional Chinese medicine (TCM) symptom score, measured on days 0, 30, and 60. Safety indicators, including liver function, kidney function, blood routine, glucose, blood lipid, blood pressure, and heart rate were tested on days 0 and 60 of the trial. The data were analyzed using Prism 9 software, and the significance level was set at P < .05.

Results

Among 119 participants, six in the LQT granule group and seven in the placebo group dropped out, and 106 participants completed clinical observation. Baseline information, including SUA levels, TCM symptom scores, and other clinical characteristics, did not differ between the groups. At the end of the trial, compared with baseline values, the SUA levels in the LQT granule group decreased (P < .001), and no significant change was observed in the placebo group (P =.422); compared with the placebo group, the SUA levels decreased in the LQT granule group (P =.001). Compared with baseline values, the total TCM symptom scores in the LQT granule group decreased (P < .001), with no change in the placebo group (P =.136). Safety indicators did not differ significantly between the two groups.

Conclusion

The pilot trial demonstrated the potential of LQT granules to lower SUA levels and improve symptoms of dampness and heat.

Open Access Original Article Issue
Elucidation of the hepatoprotective effect and mechanism of Melastoma dodecandrum Lour. based on network pharmacology and experimental validation
Journal of Traditional Chinese Medical Sciences 2022, 9(1): 47-58
Published: 03 January 2022
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Objective

To systematically explore the effect and mechanism of melastomatis dodecandri herba (Melastoma dodecandrum Lour.) in the treatment of hepatitis based on network pharmacology.

Method

We evaluated the hepatoprotective effects of M. dodecandrum in concanavalin A (Con A)-induced hepatitis in mice by assessing survival rate, histological analysis, serum transaminases, and related cytokines. Then the mechanism of action was predicted by a network pharmacology-based strategy. Based on the results, we measured the hepatic expression of related genes at mRNA level and proteins related to the phosphoinositide 3-kinase (PI3K)/protein kinase B (Akt) and nuclear factor-kappa B (NF-кB) pathways.

Results

Our study results clearly demonstrated that M. dodecandrum pretreatment significantly alleviated liver injury. This was demonstrated by an increase in survival rate, decreased severity of liver damage, and reduced serum transaminase levels compared with those in the Con A group. Moreover, M. dodecandrum significantly reduced the serum levels of tumor necrosis factor-α, interleukin-6, and interferon-γ and increased the liver levels of superoxide dismutase, which indicated that M. dodecandrum exhibits anti-inflammatory and antioxidant activities. On the basis of network pharmacology, 50 nodes were selected as major hubs based on their topological importance. Pathway enrichment analyses indicated that the putative targets of M. dodecandrum mostly participate in various pathways associated with the anti-inflammation response, which implies the underlying mechanism by which M. dodecandrum acts on hepatitis. Real-time fluorescent quantitative PCR analysis showed that M. dodecandrum downregulates the mRNA expression of interleukin-6, Toll-like receptor 7, interleukin-1 receptor-associated kinase-4, NF-кB and tumor necrosis factor-α in liver tissues. Western blotting showed that M. dodecandrum pretreatment protected against inflammation through activating the PI3K-Akt pathway by upregulating phosphorylated Akt (p-Akt) expression and suppressing NF-кB activation by inhibiting the phosphorylation of IKK, IκBα, and p65.

Conclusion

The present work demonstrated the hepatoprotective effects of M. dodecandrum by regulating the PI3K/Akt and NF-кB pathways in Con A-induced mice, which provide insights into the treatment of hepatitis using M. dodecandrum.

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