The Efficacy and Safety of Herbal Medicine Treatment for Obese Patients With Spinal and Joint Pain

NCT06859697 | Enrolling By Invitation DMC

• 2 other identifiers: JS-CT-2025-03Jaseng Medical Foundation
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pragmatic pilot randomized controlled trial aimed at investigating the effectiveness of herbal medicine treatment for obese patients with spinal and joint pain, using a control group receiving lifestyle guidance.

Conditions

Obesity and Overweight

Keywords

Obesity Herbal Medicine

Outcome Measures

Primary Outcomes (1)

• BMI(Body Mass Index)

  Body weight (kg) divided by the square of height (m) is used as a diagnostic criterion for obesity. Based on the significant increase in obesity-related diseases associated with body mass index (BMI), the Asia-Pacific region and the Korean Society for the Study of Obesity have established the criteria as follows: a BMI of 23 kg/m² or higher is classified as overweight or pre-obesity, and a BMI of 25 kg/m² or higher is classified as obesity.

  Change from baseline to Week 6

Secondary Outcomes (10)

• Body Fat Percentage

  Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12

• Body fat mass

  Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12

• Skeletal Muscle Mass

  Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12

• Body weight

  Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12

• Visceral fat level

  Baseline(Week 0), Week 2, Week 4, Week 6, Week 8, Week 12

Other Outcomes (1)

• Adverse Event (AE)

  Week 2, Week 4, Week 6, Week 8, Week 12

Study Arms (2)

Herbal Medicine Group

EXPERIMENTAL

Participants in the herbal medicine treatment group will visit the clinic every 14 days for prescription and follow-up observations. Herbal medicine will be prescribed in 14-day doses, and participants will orally take a total of 42 days' worth of herbal medicine during the treatment period. This study is a pragmatic clinical trial, and there are no restrictions on the types of herbal medicine used. Prescriptions will be made at the discretion of the medical staff, with the primary goal of improving obesity. All prescriptions will be made by Korean medicine doctors with at least five years of clinical experience. After the prescription is issued, the herbal medicine will be delivered to participants via courier for consumption. Participants will be instructed to store all herbal medicine in a refrigerator. Compliance with herbal medicine consumption will be confirmed by counting the remaining doses during participants' visits and recording the results.

Procedure: Herbal medicine treatment

Life Guidance Group

ACTIVE COMPARATOR

Educational materials will be distributed, and education sessions will be conducted.

Procedure: Life Guidance

Interventions

Herbal medicine treatment PROCEDURE

Herbal medicine treatment is a treatment using complex extract of medicinal herbs prescribed by a Korean medicine doctor who has completed specialized education to diagnose the health condition and symptoms of patients

Herbal Medicine Group

Life Guidance PROCEDURE

Educational materials will be distributed, and education on daily life management for weight loss will be conducted. The educational materials consist of information on the definition and causes of obesity, explanations on weight reduction and daily life management applicable to various situations such as exercise and diet, and the effects of these practices.

Life Guidance Group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 19 years or older but under 70 years.
• Individuals with a BMI of 25 kg/m² or higher, meeting the Asia-Pacific obesity criteria.
• Individuals experiencing spinal or joint pain, with the most severe pain rated as NRS 5 or higher.
• Individuals who voluntarily agree to participate in the clinical trial and sign the consent form.

You may not qualify if:

• Presence of findings on X-ray examination of the pain site, such as acute fractures or dislocations, requiring surgical intervention.
• Diagnosis of specific diseases that may cause secondary obesity (e.g., Cushing's syndrome, hypothyroidism, insulinoma, adult growth hormone deficiency, etc.).
• Current use of medications related to obesity treatment or a history of taking such medications within the past month.
• Presence of other chronic diseases that may interfere with treatment efficacy or interpretation of results, such as stroke, myocardial infarction, kidney disease, active hepatitis, diabetic neuropathy, dementia, epilepsy, etc.
• Current use of steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes.
• Unsuitability or safety concerns for herbal medicine treatment: individuals with conditions or post-surgical complications affecting drug absorption or digestion, severe liver disease, or kidney disease.
• Pregnant or planning to become pregnant, or currently breastfeeding.
• Participation in other clinical trials, except for observational studies without therapeutic intervention.
• Difficulty in providing informed consent.
• Other cases where the investigator deems participation in the clinical study inappropriate.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Hyuk Ha, PhD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 5, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)