A Randomized Controlled Trial of Phet-Sang Khat and Pak- Kard-Hau-Whan Extract Rectal Suppository

Phase 2

• Conditions: HemorrhoidProlapseBleedingPain; Cissus quadrangularis; Acmella oleracea; Spilanthes acmella; Hemorrhoid; Prolapse; Bleeding; Pain

• Registration Number: TCTR20180501002
• Lead Sponsor: Thai Traditional Medicine Research Institute (TMRI), Department for Development of Thai Traditional

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study Completion: 2018-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1. Age 18-70 years old
2. Diagnosis of internal hemorrhoids grade 1 to 3 by history taking and proctoscopy
2. Have had hemorrhoid-related bleeding or pain
3. Be able to communicate in Thai language

Exclusion Criteria

1. Pregnant or breastfeeding or having menstruation period during study timeframe
2. Known hypersensitivity to Phet-Sang Khat and/or Pak- Kard-Hau-Whan Extract
3. Previous history of anorectal surgery within 1 year
4. Diagnosis of cancer (all types)
5. Diagnosis of Inflammatory bowel disease
6. Use of any hemorrhoidal medications within 7 days before day 1
7. Use of anticoagulant drugs
8. immunocompromised patients
9. Not willing to participate in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bleeding [8 days period] Hemorrhoids-associated bleeding self-assessed by patient daily as 0-3 scale [level 0 = no bleeding, ,Size of prolapse [8 days period] Size of prolapse assessed by a physician on Day 1 and Day 8 as 0-2 scale [level 0 = non-significant

Secondary Outcome Measures

Name	Time	Method
Pain [8 days period] Hemorrhoids-associated pain self-assessed by patient daily as Visual Analog Scale (VAS) ranged 0-10