The Effect of NP-2006 on Sleep Quality and Health

Hanpoong Nature Pharm Co., Ltd.

Status: Completed

Conditions: Sleep Disorder (Disorder)

Treatments: Dietary Supplement: NP-2006; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07485959

NP2006_HPN

Details and patient eligibility

About

The main objective will be to assess the effect of NP-2006 on sleep efficiency in volunteers presented with persistent subclinical insomnia

Enrollment: 48 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Those who agreed to participate in this study and signed a written consent form
2. Adults aged 19 to 65 years, male or female
3. Those with poor sleep quality (PSQI score > 5 points)

Exclusion criteria

1. Those with severe sleep disturbances (ISI ≥ 22 points)

2. Those with severe daytime sleepiness (ESS ≥ 16 points)

3. Those with the following conditions:

   • Snoring, sleep apnea, restless legs syndrome, periodic limb movement disorder (PLMD), depression, narcolepsy, or respiratory disease that cause sleep disturbances
   • Itching, nocturia, chronic pain, or muscle cramps that affect sleep
   • Uncontrolled diabetes or hypertension

4. Those experiencing changes that could cause excessive stress within 2 weeks of the first visit: death of a spouse, family discord, lawsuits/disputes, sudden financial difficulties, immigration, etc.

5. Those taking medications (corticosteroids, psychotropic medications, etc.) that could affect sleep within 1 month of the first visit or expected to take them during the study participation

6. Those receiving hormone therapy

7. Those who regularly consume excessive alcohol

   • Men > 210 g/week (approximately 4 bottles of soju/week, approximately 4 glasses/day)
   • Women > 140 g/week (approximately 2.5 bottles of soju/week, approximately 2.5 glasses/day)

8. Those who smoke excessively (> 10 cigarettes/day) or show withdrawal symptoms

9. Those who consume excessive amounts of caffeine (> 3 cups/day)

10. Those who work night shifts or have irregular bedtimes due to their job

11. Those who have traveled or plan to travel long distances to a country with a different time zone within 1 month of the first visit

12. Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more

13. Those who have continuously taken herbal medicines or health functional foods that may affect sleep within 1 month of the first visit

14. Those who are hypersensitive to ingredients in the test or control foods or have experienced severe food allergies

15. Those who have participated in a clinical trial within 1 month of the first visit

16. Those who are pregnant or lactating, or who are planning to become pregnant

17. Those who the researcher deems unsuitable for participation in this study

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 2 patient groups, including a placebo group

Sequence A (NP-2006 first, then Placebo)

Experimental group

Description:

Group that took tablets containing 500mg of NP-2006 (NP-2006, crystalline cellulose, tapioca starch, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before going to sleep

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: NP-2006

Sequence B (Placebo first, then NP-2006)

Placebo Comparator group

Description:

Group that took tablets not containing NP-2006 (crystalline cellulose, maltodextrin, lactose mixed powder, hydroxypropylmethylcellulose, etc.) 30 to 60 minutes before bedtime

Treatment:

Dietary Supplement: Placebo

Dietary Supplement: NP-2006