Chapter 6: Phase 3 - Protocols
Standardized Clinical Protocols for Traditional Medicine Practice
6.1 Constitution Assessment Protocol
A standardized approach to constitutional assessment ensures consistency and reliability across different practitioners and settings.
Step 1: Questionnaire Administration
- Administer validated questionnaire (CCMQ for TCM, Prakriti for Ayurveda, QSCCII for Sasang)
- Ensure patient understands questions in their native language
- Allow 15-20 minutes for completion
- Record raw scores and calculate type scores
Step 2: Physical Examination
- Body type assessment (frame, weight distribution)
- Facial characteristics analysis
- Voice quality assessment
- Gait observation
Step 3: AI-Assisted Analysis (Optional)
- Facial image analysis for constitutional features
- Voice recording for acoustic analysis
- Integration with questionnaire results
- Confidence score generation
Step 4: Multi-Omics Integration (When Available)
- Pharmacogenomic markers
- Metabolomic profile
- Microbiome assessment
- Constitutional biomarker panel
6.2 Four Examinations Protocol
FOUR EXAMINATIONS WORKFLOW
===========================
┌─────────────────┐
│ 1. INSPECTION │ ──▶ Tongue photo ──▶ AI Analysis
│ (望診) │ ──▶ Complexion ──▶ Color mapping
│ │ ──▶ Spirit ──▶ Vitality score
└────────┬────────┘
│
▼
┌─────────────────┐
│ 2. AUSCULTATION │ ──▶ Voice recording ──▶ Frequency analysis
│ (聞診) │ ──▶ Breathing ──▶ Pattern detection
│ │ ──▶ Body odor ──▶ Documentation
└────────┬────────┘
│
▼
┌─────────────────┐
│ 3. INQUIRY │ ──▶ Chief complaint
│ (問診) │ ──▶ Ten Questions (十問)
│ │ ──▶ Medical history
│ │ ──▶ Lifestyle factors
└────────┬────────┘
│
▼
┌─────────────────┐
│ 4. PALPATION │ ──▶ Pulse diagnosis ──▶ Sensor/Manual
│ (切診) │ ──▶ Abdominal palpation
│ │ ──▶ Acupoint tenderness
└────────┬────────┘
│
▼
┌─────────────────────────────────────┐
│ PATTERN SYNTHESIS │
│ ───────────────────────────────── │
│ • Integrate all examination data │
│ • Apply pattern recognition │
│ • Generate ICD-11 TM codes │
│ • Create treatment principle │
└─────────────────────────────────────┘
6.3 Tongue Diagnosis Protocol
Image Capture Standards
- Lighting: Natural daylight or 5500K color-corrected light
- Timing: Before eating, drinking, or brushing teeth
- Position: Tongue extended naturally, not stretched
- Duration: Capture within 15 seconds to avoid color change
- Equipment: Smartphone with standardized color reference card
Analysis Parameters
- Body Color: Pale, Light Red, Red, Dark Red, Purple
- Body Shape: Thin, Normal, Swollen, Teeth-marked
- Coating Color: White, Yellow, Gray, Black
- Coating Thickness: Thin, Normal, Thick, Peeled
- Moisture: Dry, Normal, Wet
- Special Features: Cracks, spots, sublingual veins
6.4 Pulse Diagnosis Protocol
Manual Pulse Taking
- Patient rests for 5 minutes before examination
- Arm at heart level, palm facing up
- Locate three positions: Cun, Guan, Chi on radial artery
- Apply three pressure levels: superficial, middle, deep
- Assess rate, rhythm, and 28 classical pulse qualities
- Compare left and right, note positional variations
Sensor-Based Pulse Capture
- Sensor Type: Piezoelectric or optical
- Sampling Rate: ≥1000 Hz
- Duration: Minimum 60 seconds
- Positions: All three positions sequentially
- Output: Time-domain waveform, frequency spectrum
6.5 Treatment Protocol
Treatment Selection Framework:
- Pattern → Principle: Determine treatment principle from pattern diagnosis
- Principle → Formula: Select classical formula matching principle
- Constitution → Modification: Adjust formula based on constitution
- Individual → Dosage: Calculate dosage based on age, weight, severity
- Safety → Check: Screen for drug interactions and contraindications
6.6 Safety Monitoring Protocol
Adverse Event Reporting
- Standardized AE form compatible with WHO UMC format
- Causality assessment using Naranjo scale
- Severity grading (mild, moderate, severe, life-threatening)
- Real-time reporting to pharmacovigilance database
- Signal detection and safety alert system
Quality Control Checkpoints
- Herb identity verification (DNA barcode if needed)
- Heavy metal testing (As, Pb, Hg, Cd)
- Pesticide residue screening
- Microbial contamination testing
- Active compound content verification