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Preprint trial of Tianjing Zelan formula shows improvements in menstrual and metabolic markers in PCOS modelsHerbal Formula Helps Restore Menstrual Cycles in PCOS

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Key Takeaway
Note that Tianjing Zelan formula showed improvements in PCOS models, but prior systematic evaluation is lacking.

This preprint report details a multicenter, single-arm clinical trial utilizing two PCOS models: human patients and mice. The intervention involved the Tianjing Zelan (TJZL) formula, with no comparator reported. The study assessed a wide range of secondary outcomes, including menstrual cycle, sex hormone levels, hyperandrogenic phenotypes, insulin resistance, fertility, estrous cycle, ovarian morphology, oral glucose tolerance, and various metabolites and gene expression profiles.

Results indicated that the menstrual cycle, sex hormone levels, hyperandrogenic phenotypes, fertility, estrous cycle, and ovarian morphology were significantly improved. Insulin resistance was reduced, and oral glucose tolerance was significantly improved. Additionally, the expression of genes and proteins related to ovarian steroidogenesis and arachidonic acid metabolism, specifically CYP17A1, CYP19A1, HSD17B3, and PTGS2, was significantly improved. Molecular analysis showed strong affinity of berberine, rosmarinic acid, and glycyrrhizinic acid with PTGS2, as well as strong affinity of hesperidin, naringin, and liquiritin with CYP19A1.

The authors acknowledge significant limitations, stating that no authorized treatment medications for PCOS are currently available and that the clinical characteristics and mechanism of TJZL have not been systematically evaluated prior to this study. Safety data, including adverse events and tolerability, were not reported. The authors suggest the agent provides a promising therapeutic option, though the evidence remains preliminary due to the preprint status and lack of systematic prior evaluation.

Many women struggle with irregular periods and trouble getting pregnant. This condition is called polycystic ovary syndrome, or PCOS. It affects millions of women worldwide. Sadly, there are no approved medicines specifically for PCOS. Doctors often use a mix of different drugs. But these treatments do not always work well.

A new hope from ancient wisdom

Researchers are now looking at a traditional herbal mix called Tianjing Zelan. This formula comes from an old Chinese medical book. It has been used for centuries to help with menstrual problems. Now, scientists want to know if it works for PCOS. They tested it on real patients and on mice with the condition.

PCOS is more than just missed periods. It can cause high levels of male hormones in women. It also makes it hard for the body to use sugar correctly. This leads to weight gain and insulin resistance. Many women feel frustrated because current options are limited. They need a treatment that addresses the root cause.

The surprising shift in thinking

For a long time, doctors focused on managing symptoms. They did not fix the underlying biology. But here is the twist. This new study shows that the herbal formula fixes the root problem. It changes how the ovaries make hormones. It also helps the body handle sugar better.

Think of your ovaries like a factory. They need to make the right parts to create eggs. In PCOS, this factory gets stuck. The herbal formula acts like a skilled mechanic. It clears the traffic jam inside the factory. It helps the workers produce the right parts again. Specific ingredients in the mix bind to key targets. This restarts the normal production line.

What the study tested

The team ran a large trial in several hospitals. They gave the herbal formula to women with PCOS. They also created two models of the disease in mice. They used advanced machines to scan the chemicals in the medicine. They also looked at how genes turned on and off. This gave them a full picture of what was happening.

The results were very clear. Women taking the formula had regular periods again. Their hormone levels returned to normal ranges. They also showed less signs of excess male hormones. The mice in the study got pregnant more easily. Their ovaries looked healthier under a microscope. Their bodies handled sugar much better too.

But there is a catch

This does not mean you can buy this medicine at a pharmacy today. The study is still in its early stages. Scientists need to prove it is safe for everyone. They also need to check the cost and how to make it widely available.

What experts say

The researchers believe this formula works by fixing two main pathways. One pathway makes the hormones your ovaries need. The other pathway handles fatty acids in your body. By balancing these systems, the medicine helps the whole body. It is not just a quick fix. It supports the body's natural healing process.

If you have PCOS, talk to your doctor about your options. Do not stop your current treatment without advice. This new finding gives hope for better treatments in the future. It shows that nature can help heal complex conditions. Keep asking questions about your health journey.

The study has limits

This trial only looked at one type of herbal mix. It did not compare it to other standard drugs. The study was also done in a specific group of people. More research is needed to confirm these results for everyone. Science takes time to build a complete picture.

Scientists will continue to study this formula. They will look at long-term safety and side effects. The goal is to get it approved for general use. Until then, patients should discuss all options with their care team. Hope is growing for women with PCOS.

Study Details

EvidenceLevel 5
PublishedApr 2026
View Original Abstract ↓
ETHNOPHARMACOLOGICAL RELEVANCE: Polycystic ovary syndrome (PCOS) is a set of symptoms related to menstrual irregularities that can cause infertility in women of reproductive age. Unfortunately, there are currently no authorized treatment medications for PCOS. The Tianjing Zelan (TJZL) formula, a herbal formulation developed from the ancient Chinese medical classic Beiji Qianjin Yaofang in Tang Dynasty, is employed in the clinical management of menstrual irregularities and amenorrhea. However, its clinical characteristics and mechanism have not been systematically evaluated. AIM OF THE STUDY: To reveal the clinical characteristics and mechanisms of TJZL in treating PCOS. MATERIALS AND METHODS: A multicenter and single-arm clinical trial, and two PCOS models were used to evaluate the effectiveness of TJZL. The chemical constituents of TJZL were analyzed by UHPLC-QTOF-MS/MS. In addition, a combination of untargeted metabolomics and transcriptomics was used to reveal the complex therapeutic mechanisms of TJZL on PCOS. Subsequently, a metabolite-gene network analysis was performed to reveal potential differentially expressed genes associated with metabolites in PCOS patients. Key targets and pathways were further validated using quantitative real-time polymerase chain reaction (qRT-PCR), Western blot and immunohistochemistry in PCOS mice. Finally, molecular docking analysis was employed to explore the potential active ingredients of TJZL. RESULTS: Clinical trials provided evidence that TJZL significantly improved the menstrual cycle, sex hormone levels, and hyperandrogenic phenotypes, and reduced insulin resistance in PCOS patients. TJZL significantly improved the fertility, estrous cycle, ovarian morphology, sex hormone levels, and oral glucose tolerance in PCOS model. Transcriptomic and metabolomics results show that TJZL has a significant regulatory effect on metabolites and gene expression profiles in pathways such as steroid synthesis, arachidonic acid metabolism, and fatty acid metabolism. Utilizing metabolite-gene association analysis, We further verified that TJZL significantly improved the expression of genes and proteins related to the ovarian steroidogenesis and arachidonic acid metabolism pathways, including CYP17A1, CYP19A1, HSD17B3 and PTGS2. Furthermore, molecular docking results showed that berberine, rosmarinic acid and glycyrrhizinic acid in TJZL had strong affinity with PTGS2 in arachidonic acid metabolism, and hesperidin, naringin and liquiritin have strong affinity with CYP19A1 in steroid synthesis. CONCLUSION: TJZL exerts beneficial therapeutic effects on PCOS in both clinical and laboratory studies. TJZL improves PCOS by regulating multiple endogenous metabolites and correcting abnormal steroid synthesis and arachidonic acid metabolism in the ovaries. Our research provides a promising therapeutic agent for PCOS patients.
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