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NOT YET RECRUITING
NCT07504536
PHASE2

Ning Shen Dan Xiang Gao Fang for Heart-Kidney Disharmony Insomnia

Sponsor: Shanghai 7th People's Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if Ning Shen Dan Xiang paste combined with Ejiao (donkey-hide gelatin) works better than Ning Shen Dan Xiang paste combined with agar (placebo substitute) to treat chronic insomnia of the heart-kidney disharmony type in adults. It will also assess safety. The main question is: \- Does Ning Shen Dan Xiang + Ejiao improve sleep quality more than the placebo version, as shown by the change in Pittsburgh Sleep Quality Index (PSQI) score after 8 weeks? Researchers will compare the two pastes (identical in appearance and taste except for Ejiao) and use published literature data as an additional external control. Participants will: Take 20 g of the assigned paste twice daily (morning and evening) for 8 weeks. Attend clinic visits at baseline, week 4, week 8, and 1 week after stopping (week 9 follow-up). Complete PSQI and ISI questionnaires, keep a daily electronic sleep diary, provide blood/stool samples, and undergo safety monitoring (blood/urine tests, ECG, vital signs, and side effect checks).

Official title: A Randomized, Double-Blind, Dual-Control (Internal and External) Clinical Study of Ning Shen Dan Xiang Gao Fang in the Treatment of Insomnia (Heart-Kidney Disharmony Type)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-03-15

Completion Date

2028-12-31

Last Updated

2026-04-01

Healthy Volunteers

No

Conditions

Interventions

DRUG

Ningshen Danxiang Donkey-hide Gelatin Medicated Paste

Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals.

DRUG

Ningshen Danxiang Agar Medicated Paste (agar as excipient)

Take 1 bag each time (each bag contains 20 g of crude herbal drug). Dissolve in warm boiled water and take orally, once in the morning and once in the evening. It is optimal to take on an empty stomach. Continue for 8 consecutive weeks. If gastrointestinal discomfort occurs when taken on an empty stomach, it may also be taken after meals.

Locations (1)

Shanghai Seventh People's Hospital

Shanghai, Pudong New Area, China