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

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).

Conditions

• Insomnia

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.

Sponsors & Collaborators

• Innovation Research Institute of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Institute of Digestive Diseases, Shanghai University of Traditional Chinese Medicine

  collaborator UNKNOWN

• Center for Pharmacometrics, Shanghai University of Traditional Chinese Medicine

  collaborator UNKNOWN

• DongE E Jiao Coporation Limited

  collaborator INDUSTRY

• Shanghai 7th People's Hospital

  lead OTHER

Principal Investigators

• Xiaodan Zhang, Ph.D · Shanghai 7th People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-15

Primary Completion

2027-03-31

Completion

2028-12-31

Countries

• China

Study Locations