Here is the design of a clinical trial:

Official Title: Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: a Multicenter Randomized Controlled Trial

Included conditions:
- Chronic Prostatitis With Chronic Pelvic Pain Syndrome

Study Armgroups:
- {'label': 'Acupuncture', 'type': 'EXPERIMENTAL', 'description': 'The participants in the acupuncture group will receive treatment that consists of 20 acupuncture sessions over an 8-week (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks) period after baseline, each for 30 minutes. Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Sanyinjiao (SP6), Zhongliao (BL33), Shenshu (BL23), and Huiyang (BL35), were selected as acupoints protocol. SP6 is on the tibial aspect of the leg, posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus; BL32 is in the sacral region, in the second posterior sacral foramen; BL33 is in the third posterior sacral foramen; BL35 is in the buttock region, 0.5 cun lateral to the extremity of the coccyx.', 'interventionNames': ['Device: Acupuncture']}
- {'label': 'Sham acupuncture', 'type': 'SHAM_COMPARATOR', 'description': 'The participants in the sham acupuncture group will receive shallow needling at bilateral sham BL23, BL33, BL35 and SP6. The protocol includes the same duration and frequency of sessions as for the acupuncture treatment, but the treatment was delivered superficially at non-acupuncture points 10-15 mm to the lateral of corresponding acupuncture and not above a meridian line (15mm to BL23, BL33 and BL35; 10mm to SP6). The Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be inserted with a depth of 2-3 mm without any manipulation.', 'interventionNames': ['Device: Sham acupuncture']}

Interventions:
- {'type': 'DEVICE', 'name': 'Acupuncture', 'description': 'For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.\n\nAcupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).', 'armGroupLabels': ['Acupuncture']}
- {'type': 'DEVICE', 'name': 'Sham acupuncture', 'description': 'For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.\n\nSham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks).', 'armGroupLabels': ['Sham acupuncture']}

Primary Outcomes:
- {'measure': 'Proportion of Responders at the End of 8-week', 'description': 'The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI).', 'timeFrame': 'week 8'}
- {'measure': 'Proportion of Responders at the End of 32-week', 'description': 'The responder is defined as who has a decline of 6 or more than 6-point from baseline measured by using the NIH-CPSI.', 'timeFrame': 'week 32'}

Please estimate the sample size based on the assumption: 
The calculations are based on 90% power, a two-sided alpha level of 0.05, and a 15% increase to account for dropouts. All hypothesis testing will be carried out at the 5% (two-sided) significance level.
Calculation of sample size and statistical analyses
        The primary study hypothesis is that acupuncture is more effective than sham acupuncture in relieving symptoms of CP/CPPS. Sample-size calculations were based on 90% power to detect a difference of 17% between response rates in the two groups (63.7% in the acupuncture group compared with 46.7% in the control group) for the primary outcome, defined as a decline of 6 or more points in the NIH-CPSI total score [21]. These values are equivalent to an odds ratio of 2.0. On the basis of a two-sided alpha level of 0.05, we calculated that a sample of 440 participants will be required (220 in each group). This proposed sample size includes a 15% increase to account for dropouts. To control for type I error, the two time points will have to be positive in order for the trial to prove the efficacy of acupuncture.
        Summary tables (descriptive statistics and/or frequency tables) will be provided for all variables as appropriate. Means and standard deviations will be presented for continuous variables, unless the variable has a skewed distribution, in which case medians, and 25th and 75th percentiles will be presented. The number and percentage of participants in each category will be presented for categorical variables. Missing values will be reported for each variable (continuous or categorical). All randomized participants will be included in the analyses. All analyses will be based on the intention-to-treat principle.
        Primary outcome analysis will be conducted with a logistic generalized linear mixed model (GLMM) for repeated measures. Response or non-response at each scheduled post-baseline visit (end of treatment, and 20 and 24Â weeks after treatment) is the dependent variable. Subjects who discontinue without providing a post-baseline NIH-CPSI score will be considered non-responders at visit 1 (week 1). The logistic GLMM is fit using the logit link and the binomial distribution. The model will include the baseline NIH-CPSI total score as a fixed-effect covariate, with fixed-effect categorical factors for a treatment group (acupuncture and sham acupuncture), visit and treatmentâÃâvisit interaction. The interaction will remain in the model regardless of significance. Treatment group comparisons at each visit will be estimated by differences between least squares means from the treatmentâÃâvisit interaction, and will be presented as odds ratios with accompanying p values and 95% CIs. The predicted probability of response at each visit will also be presented. Such models provide fairly robust results for treatment comparisons when longitudinal binary responses are missing, with an assumption that data are missing at random, according to reported values [45]. Sensitivity analysis will be performed if necessary, with a control-based pattern imputation model under the assumption of missing not at random.
        Changes from baseline in the NIH-CPSI total score will be analyzed using linear mixed-effects models. The observed change from baseline score at each assessment point will be considered as the dependent variable. The model will include the baseline value, treatment group (acupuncture and sham acupuncture), visit and treatmentâÃâvisit interaction. Treatment group comparisons at each visit will be estimated by differences between least squares means from the treatmentâÃâvisit interaction, with accompanying p values and 95% CIs. Log-transformation may be applied in the case of serious violations of the model assumptions (normality and constant variance of the residuals). If not appropriate, the Wilcoxon rank-sum test will be used. The effect of the treatment will be estimated by the difference (or ratio, in the case of log-transformation) between treatments and will be presented along with its associated 95% CI. The same approach as for the NIH-CPSI total score will be used in other longitudinal continuous outcomes such as NIH-CPSI subscales (pain, urinary symptoms, and QoL).
        Other categorical data or ordinal data will be compared between groups using the Wilcoxon rank-sum test, chi-square test or Fisherâs exact test, as appropriate. The James and Bang blinding indices will be used to assess the success of blinding. The James blinding index is a variation on the statistic in which 1 represents perfect blinding. The Bang blinding index for each group represents the proportion of participants making a correct treatment guess beyond chance; 0 represents perfect blinding, a positive index indicates a correct guess, and a negative index indicates a guess in the opposite direction [46]. For all statistical analyses, SAS 9.4 software will be used. All hypothesis testing will be carried out at the 5% (two-sided) significance level.