The Clinical Research of Traditional Chinese Medicine Compound Formulas

NCT ID: NCT07153731

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2027-07-01

Brief Summary

To observe the efficacy and safety of Shenkangling, a traditional Chinese medicine decoction, for renal ischemia-reperfusion injury, and to provide evidence-based medical evidence and ideas for clinical therapeutic use.

Detailed Description

1. Study Design and Methods 1.1 Research Method A multicenter, open-label study design is employed. 1.2 Source of Participants Clinical observation cases are from patients with ischemia-reperfusion injury caused by partial nephrectomy or renal exploration, admitted between March 2025 and December 2026 to the Department of Urology at Zhejiang University School of Medicine Fourth Affiliated Hospital and Fujian University of Traditional Chinese Medicine Affiliated People's Hospital. A total of 100 subjects are included.

1.3 Participant Selection and Exclusion Criteria 1.3.1 Western Medicine Diagnostic Criteria

1. Partial nephrectomy due to renal tumor: Based on the "Chinese Expert Consensus on Laparoscopic and Robotic Partial Nephrectomy for Renal Tumors," the general diagnosis of renal tumor should be met, with the maximum tumor diameter ≤ 4 cm, and the indication for partial nephrectomy.

2. Partial nephrectomy due to renal cyst: Based on the "Consensus on the Safety of Surgical Treatment for Simple Renal Cysts," the general diagnosis of renal cyst should be met, and partial nephrectomy should be indicated.

3. Partial nephrectomy or renal exploration due to renal injury: According to the "Urological Injury Diagnosis and Treatment Guidelines" issued by the Chinese Urological Association, injuries such as renal contusion, partial renal laceration, complete renal laceration, and renal pedicle injury caused by open or closed trauma, which are indications for partial nephrectomy or renal exploration.

4. Partial nephrectomy due to renal hamartomas, complex renal cysts, or other conditions: Based on the "2022 Edition of the China Urological and Andrological Diseases Diagnosis and Treatment Guidelines," the general diagnosis of these diseases should be met, and partial nephrectomy should be indicated.

1.3.2 Traditional Chinese Medicine Diagnostic Criteria

Based on clinical manifestations and the "Guidelines for Clinical Research on New Chinese Medicines" and "General Principles for Clinical Research on New Chinese Medicines" established by the People's Republic of China, and referring to the opinions of various scholars, the criteria are as follows:

Kidney Deficiency and Blood Stasis Syndrome Main Symptoms: Low back and spine soreness or stabbing pain or fixed pain, fatigue, swelling, susceptibility to colds, afternoon fever, palms and soles of the feet hot, dark or dull complexion.

Secondary Symptoms: Dry mouth, dry throat, dark red throat, skin and nails rough or numb limbs, tongue red or slightly red, or tongue purple and dark with bruises or spots, thin pulse.

At least one main symptom and at least two secondary symptoms must be present, with tongue and pulse findings consistent.

1.3.3 Inclusion Criteria

1. Meets the Western medical diagnostic criteria, requiring renal ischemia-reperfusion surgery with renal artery occlusion time ≤ 30 minutes;

2. Meets the Traditional Chinese Medicine syndrome differentiation criteria;

3. Age between 18 and 65 years;

4. Voluntary participation and signing of informed consent. 1.3.4 Exclusion Criteria

(1) Patients with stage 4 or 5 renal failure or acute renal failure; (2) Diagnosed with systemic lupus erythematosus, drug-induced kidney damage, or other secondary causes; (3) Not meeting the diagnosis of renal ischemia-reperfusion injury; (4) Not within the scope of the drug's effect; (5) Long-term use of other related drugs, such as those on long-term oral Chinese medicines like Jin Kui Shen Qi Wan, or unable to stop the medication immediately; (6) Severe deformities, disabilities, or loss of work ability; (7) Co-existing severe primary diseases such as heart, brain, liver, hematological, or endocrine system diseases, and psychiatric disorders; (8) Pregnant or breastfeeding women; (9) Critically ill patients; (10) Other conditions deemed unsuitable for inclusion by the researchers. 1.3.5 Participant Withdrawal 1.3.5.1 Investigator-Determined Withdrawal

1. The investigator determines that it is necessary to stop the study from an ethical perspective;

2. Serious adverse events occur, and the participant should no longer continue the trial;

3. Serious co-morbidities arise during treatment;

4. The investigator determines that withdrawal from the study is in the participant's best interest;

5. Other reasons. 1.3.5.2 Participant-Determined Withdrawal Participants have the right to withdraw from the trial at any stage, or if the participant does not withdraw informed consent but fails to continue medication or follow-up, they are considered lost to follow-up.

1.3.6 Dropout Criteria

1. Serious adverse events or complications occur;

2. The participant requests to withdraw from the trial during the study;

3. Unable to contact the participant during the trial. 1.3.7 Exclusion Criteria

(1) Found to not meet inclusion criteria after enrollment; (2) Poor compliance with the study protocol, including not following prescribed medication or clinical tests; (3) Incomplete data during the trial, making it impossible to evaluate the drug's efficacy and safety.

2.4 Treatment Plan and Grouping 2.4.1 Trial Medication Shenkangling Composition: Astragalus, Rehmannia, Cornus, Dioscorea, Poria, Moutan Root Bark, Panax Notoginseng, etc.

Formulation: Decoction Dosage: 150 ml per dose Source: Zhejiang Sanxi Tang Chinese Medicine Co., Ltd. 2.4.2 Grouping This study involves two groups: Patients are randomly divided into the control group and experimental group, each with 40 cases. The control group receives standard treatment (post-operative anti-infection, fluid supplementation, and symptomatic treatment), while the experimental group receives Shenkangling decoction orally on top of standard treatment (one dose per day, split into two doses: one 30 minutes before breakfast and one 30 minutes after dinner).

Randomization Method: Random numbers (1-96) are generated using SPSS software and randomly assigned to the Shen Kang Ling group and the control group, each receiving 48 numbers. The distribution results are kept confidential by the group leader, who determines and records the grouping and sequence number of patients.

2.5 Statistical Analysis Method SPSS v22.0 will be used for statistical analysis. Categorical data will be analyzed using the χ² test. Continuous data will be presented as means ± standard deviations (SD) and compared using t-tests. Statistical significance is set at p < 0.05.

Conditions

Urologic Injuries; Urology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

No treatment

Group Type: NO_INTERVENTION

No interventions assigned to this group

Shenkangling group

Shenkangling

Group Type: EXPERIMENTAL

Shenkangling

Intervention Type: DRUG

Chinese herbal tonics taken orally: Shenkangling, one dose, 2 times a day, 1 time before breakfast and 1 time 30 minutes after dinner.

Interventions

Shenkangling

Chinese herbal tonics taken orally: Shenkangling, one dose, 2 times a day, 1 time before breakfast and 1 time 30 minutes after dinner.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Fulfillment of western medical diagnostic criteria requiring renal ischemia-reperfusion surgical operation and renal artery clamping time ≤ 30 min

2. Meets the criteria for Chinese medicine identification

3. 18 ≤ age ≤ 65

4. Voluntary participation with signed informed consent

Exclusion Criteria

1. Patients with stage 4 or 5 renal insufficiency or patients with acute renal failure

2. Those with secondary factors such as systemic lupus erythematosus, drug-induced renal damage, etc. confirmed by examination

3. Does not meet the diagnosis of renal ischemia-reperfusion injury

4. Cases not within the scope of action of the drug

5. Those who have been taking other related therapeutic drugs for a long period of time, e.g., taking Chinese medicines such as Jingui Shenqi Pills by mouth for a long period of time, or those who are unable to stop taking the medicines immediately.

6. Advanced deformity, disability, loss of labor force

7. Combined heart, brain, liver, hematopoietic system, endocrine system and other serious primary diseases and psychiatric patients

8. Pregnant or lactating women

9. Critically ill patients

10. Other circumstances deemed inappropriate for inclusion in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Yiwu, Zhejiang, China

Countries

China

Central Contacts

Hao Zhou, Master's Degree

Role: CONTACT

haozhou@zju.edu.cn

+8618959117277

Hui Yin Mao, Doctorate

Role: CONTACT

yinhui.mao@zju.edu.cn

+8615764372879

Facility Contacts

Yi Jia Ye

Role: primary

jigoulunli_zy4y@163.com

+86 0579-89935052

Other Identifiers

KY-2025-042

Identifier Type: -

Identifier Source: org_study_id