Using a traditional Chinese herbal treatment to reduce period pain related to a mix of cold and heat symptoms
| ISRCTN | ISRCTN60424612 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN60424612 |
| Sponsor | Xiangshan Hospital of Traditional Chinese Medicine Medical & Health Group |
| Funder | Investigator initiated and funded |
- Submission date
- 13/03/2026
- Registration date
- 17/03/2026
- Last edited
- 16/03/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Yuqiong Gao
Public, Scientific, Principal investigator
Public, Scientific, Principal investigator
No. 7 Xingyang Road, Danxi Street, Xiangshan County
Ningbo
315700
China
 ORCID ID |
0009-0002-9177-7407 |
|---|---|
| Phone | +86 13736088447 |
| Gao_yuqiong59@163.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Dose comparison |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Modified Chaihu Guizhi Ganjiang decoction in treating dysmenorrhea with cold-heat complex pattern: a randomized controlled trial |
| Study objectives | |
| Ethics approval(s) |
Approved 31/07/2024, Xiangshan Hospital of Traditional Chinese Medicine Medical & Health Group (No. 7 Xingyang Road, Danxi Street, Xiangshan County, Ningbo, 315700, China; +86 0574-65655700; xszyy2006@126.com), ref: XZYJ-2024-002 |
| Health condition(s) or problem(s) studied | Dysmenorrhea |
| Intervention | This was a prospective randomized controlled study. Seventy patients with dysmenorrhea were recruited from the Xiangshan County Hospital of Traditional Chinese Medicine Healthcare Group between June 2021 and October 2025. Eligible patients were randomly assigned in a 1:1 ratio to the experimental group (oral administration of modified Chaihu Guizhi Ganjiang Decoction) or the control group (oral administration of Ibuprofen Sustained-Release Capsules) using a random number table. The specific randomization scheme was generated by an independent statistician not involved in patient recruitment, intervention, or data collection using SPSS 25.0. The assignments were sealed in sequentially numbered, opaque envelopes. Upon enrollment of an eligible patient, the study coordinator opened the envelope with the corresponding serial number to reveal the group assignment and implement allocation, ensuring allocation concealment. Due to the different nature of the interventions (Chinese herbal decoction vs. Western medicine capsule), blinding of treating physicians and patients was not feasible. However, to reduce measurement bias, blinding was implemented for the researchers (outcome assessors) responsible for collecting primary outcome measures (including VAS score, CMSS score, and TCM syndrome score). Outcome assessors were not involved in treatment administration and remained unaware of patients' group assignments during data collection and analysis. This study was approved by the Ethics Committee . All participating patients provided written informed consent. This study employed a two-group parallel-design RCT. Sample size estimation was based on the total effective rate post-treatment as the primary evaluation indicator. According to preliminary trial results, the estimated total effective rate was approximately 90% for the experimental group and 75% for the control group. Setting the significance level α = 0.05 (two-tailed test) and statistical power (1-β) = 0.80, and using the sample size calculation formula for comparing two rates, the required sample size per group was approximately 32. Considering potential dropouts and loss to follow-up during the study, a 20% dropout rate was factored in, ultimately determining a sample size of 35 per group, totaling 70 participants. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | administration of modified Chaihu Guizhi Ganjiang Decoction;administration of Ibuprofen Sustained-Release Capsules |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) | |
| Completion date | 13/02/2025 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 40 Years |
| Sex | Female |
| Target sample size at registration | 70 |
| Total final enrolment | 70 |
| Key inclusion criteria | 1. Meeting the above Western medicine diagnostic and TCM pattern differentiation criteria 2. Regular menstrual cycles 3. No hormonal therapy in the preceding three months, and no use of other medications for dysmenorrhea one month prior to or during the treatment period 4. Voluntary participation and provision of signed informed consent |
| Key exclusion criteria | 1. Presence of an intrauterine device 2. Age <18 or >40 years, or history of irregular menstruation 3. Comorbid severe diseases of vital organs (heart, liver, kidney, brain, etc.) 4. History of allergy to the study medications 5. History of mental illness 6. Treatment history for the condition within the past 2 months 7. Women planning pregnancy, pregnant, or lactating |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 01/01/2025 |
Locations
Countries of recruitment
- China
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan |
Editorial Notes
13/03/2026: Trial's existence confirmed by Xiangshan Hospital of Traditional Chinese Medicine Medical & Health Group.
