Effects of Keluoxin capsule combined with losartan potassium on diabetic kidney disease: study protocol for a randomized double-blind placebo-controlled multicenter clinical trial

Table 3 Traditional Chinese medicine (TCM) symptom assessment survey and evaluation standard

Signs/symptoms		Score				Scores
Signs/symptoms		Normal: 0	Mild: 2	Moderate: 4	Severe: 6	Scores
Primary signs/symptoms	Dry mouth and throat	None	Decreased saliva production	Moderate thirst relieved by drinking fluids	Severe thirst with constant need to drink fluids
Primary signs/symptoms	Fatigue	None	Cannot sustain heavy work	Can manage mild intensity work	Can only perform daily activities
Secondary signs/symptoms	Prone to be hungry and eat more	None	Easy to be hungry	Easy to be hungry and unbearable hunger	Unbearable hunger and hypoglycemia
	Shortness of breath	None	Shortness of breath after mild activity	Shortness of breath after moderate activity	Unable to talk or catch breath even without activity
	Heat sensation in chest, palms, and soles	None	Heat sensation in palms and soles at night	Moderate heat sensation in chest, palms and soles	Severe heat sensation in chest, palms, and soles and desire to expose body
	Fixed pain in the chest, lower back, or limbs	None	Occasional and relieved spontaneously within half an hour	Less than three hours a day, relieved by common drugs	Continuously fixed pain, relieved only by painkillers
	Numbness of the limbs	None	Tips of hands and feet	Hands and feet	Limbs
Tongue and pulse	Tongue	Dark red tongue with less fluid coating; others (description):
Tongue and pulse	Pulse	Weak and thin pulse; others (description):

Manifestation of tongue and pulse is only for reference without being calculated in the scores
Evaluation standard of total effective rate of TCM syndrome scale score
(1) Clinical recovery: the clinical symptoms and signs disappear or basically disappear, and syndrome scores are reduced by ≥ 95%
(2) Significantly effective: the clinical symptoms and signs are significantly improved, and syndrome scores are reduced by ≥ 70%
(3) Effective: the clinical symptoms and signs are improved, and syndrome scores are reduced by ≥ 30%
(4) Invalid: the clinical symptoms and signs are not improved, or even worsened, and syndrome scores are reduced by less than 30%
The calculation formula (Nimodipine method) is as follows: [(scores before treatment − scores after treatment) ÷ scores before treatment] × 100%
Total effective rate = (clinical recovery + significantly effective + effective) number of cases/total number of cases × 100%
The total effective rate of the KLX group and the control group after treatment is calculated and compared

ISSN: 1745-6215