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Demonstration study on in-depth development and clinical transformation of Chinese herbal medicines(also food) and formulas from Shandong Province - Chronic Fatigue Syndrome

Demonstration study on in-depth development and clinical transformation of Chinese herbal medicines(also food) and formulas from Shandong Province - Chronic Fatigue Syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076824
Enrollment
Unknown
Registered
2023-10-20
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Fatigue Syndrome

Interventions

Experimental group with Qi and Blood Deficiency:Songhua Shenbao tablet
Control group with Qi and Blood Deficiency:Songhua Shenbao tablet Placebo
Experimental group with deficiency of lung and spleen qi:Shenhuang Huaishan granule
Control group with deficiency of lung and spleen qi:Shenhuang Huaishan granule Placebo
Experimental group with spleen-kidney deficiency:Fermented plant drink of Renshen and Huangjing
Control group with spleen-kidney deficiency:Fermented plant drink of Renshen and Huangjing Placebo
Experimental group with spleen stomach qi deficiency:Mixed pellets of six nutritious plant extracts
Control group with spleen stomach qi deficiency:Mixed pellets of six nutritious plant extracts Placebo

Sponsors

Affiliated Hospital of Shandong University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Chronic fatigue syndrome must meet the following criteria: (1) Meet the diagnostic criteria of chronic fatigue syndrome; (2) Age 18-60 years old, male or female; (3) Informed and voluntary acceptance of chronic fatigue syndrome product treatment; (4) Comprehensive physical examination found no abnormalities; (5) After a brief oral test, it is determined that there is no abnormal mental state, including emotional, intellectual and personality characteristics; In addition, the dialectical criteria of each syndrome type are as follows: (1) Qi and blood deficiency syndrome: the main symptoms: pale face, low speech and voice, spirit fatigue, lazy action; Secondary symptoms: shortness of breath, dizziness, chest tightness palpitation, insomnia, spontaneous sweating, hair loss, normal easy to catch a cold; Tongue and pulse: Pale tongue, white fur, thin pulse. (2) Lung Qi deficiency syndrome: main symptoms: wheezing and coughing shortness of breath, insufficient intake, abdominal distension and loose stool; Secondary symptoms: facial buoyancy, lower limbs edema, low voice lazy speech, fatigue, white face; Tongue and pulse: the tongue is light, the fur is white and smooth, the pulse is weak. (3) Spleen-kidney deficiency syndrome: main symptoms: white complexion , fear of cold, warm limbs, abdominal distension; Secondary symptoms: lazy lazy speech, low voice, waist and knee sour, dizziness and irritability, stool sticky; Tongue and pulse: the tongue is light and fat, the fur is white and smooth, the pulse is fine, heavy, late and weak. (4) Spleen-stomach Qi deficiency syndrome: main symptoms: pale yellow, spirit fatigue lazy speech, lack of energy, low voice, less food, food into difficult; Secondary symptoms: nausea and vomiting, epigastric distension, bowel singing and qi, abdominal distension and pain, loose stool; Tongue and pulse: pale tongue, white or greasy fur, thin pulse.

Exclusion criteria

Exclusion criteria: The following people should be excluded from chronic fatigue syndrome (1) clinically explainable active diseases causing fatigue, such as hypothyroidism, malignant tumors, etc.; (2) Women who are pregnant, breastfeeding or have a desire to give birth; (3) those with other serious diseases or mental illnesses; (4) Those who cannot accurately evaluate the effectiveness and safety of treatment; (5) Alcohol or drug abusers; (6) Obese, BMI=28; In addition, the exclusion criteria of each syndrome type are as follows: (1) Qi-blood deficiency type: formula contains ginseng powder, Yin deficiency internal heat can not be eaten; It contains wolfberry powder, which can not be eaten by the weak of spleen and stomach. It contains longan meat powder and red date powder, which can not be eaten by those with phlegm and dampness. (2) Lung Qi deficiency syndrome: prescription contains yam powder, yellow essence powder, phlegm-damp constitution can not be eaten; Formula contains ginseng powder, Yin deficiency internal heat can not be eaten; (3) Spleen-kidney deficiency syndrome: the formula contains jujube powder, pueraria powder, yellow essence powder, phlegm-damp constitution can not be eaten; The formula contains angelica powder, ginger powder, cinnamon powder, Yin deficiency internal heat can not be eaten; (4) Spleen and stomach Qi deficiency syndrome: the formula contains yam powder, jujube powder, jade bamboo powder, yellow essence powder, phlegm-damp physique can not be eaten.

Design outcomes

Primary

MeasureTime frame
Fatigue Rating Scale Scores;

Secondary

MeasureTime frame
Fatigue Severity Scale Scores;SF-36 Scores;

Countries

China

Contacts

Public ContactYin Yonghui

Affiliated Hospital of Shandong University of TCM

yyhszyy@163.com+86 130 6600 4500

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026