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

Sponsor
Shanghai 7th People's Hospital
Study ID
NCT07504536
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ningshen Danxiang Donkey-hide Gelatin Medicated Paste — DRUG
    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.
  • Ningshen Danxiang Agar Medicated Paste (agar as excipient) — DRUG
    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.

Study Details

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).

Key Dates

First listed
Apr 1, 2026
Start date
Mar 15, 2026
Status verified
Mar 2026
Primary completion
Mar 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ningshen Danxiang Donkey-hide Gelatin Medicated Paste
    Formula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Asini Corii Colla (E Jiao / Donkey-hide gelatin) 500 g
  • Placebo Comparator: Ningshen Danxiang Agar Medicated Paste (agar as excipient)
    Formula Composition: Mori Fructus (Sang Shen / Mulberry fruit) 300 g Ligustri Lucidi Fructus (Nü Zhen Zi / Glossy privet fruit) 300 g Polygoni Multiflori Caulis (Shou Wu Teng / Fleeceflower stem) 300 g Sedum aizoon Herba (Jing Tian San Qi / Aizoon stonecrop) 300 g Salviae Miltiorrhizae Radix et Rhizoma (Dan Shen / Red sage root) 300 g Citri Medica Fructus (Xiang Yuan / Fragrant citron fruit) 100 g Cyperi Rhizoma (Xiang Fu / Nutgrass rhizome) 100 g Agar 500 g

Primary Outcome Measure

Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline, Week 4, Week 8, Follow-up (Week 9) ]

Central Contacts

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