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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20180501002
Enrollment
140
Registered
2018-05-01
Start date
2018-05-30
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Hemorrhoid Prolapse Bleeding Pain Cissus quadrangularis Acmella oleracea Spilanthes acmella Hemorrhoid Prolapse Bleeding Pain

Interventions

Experimental,Active Comparator
Experimental: Rectal suppository containing Phet&#45
Sang Khat extract (1% w/w) and Pak&#45
Kard&#45
Hau&#45
Whan extract (10% w/w) per one suppository unit,Active Comparator: Proctosedyl® suppository contains hydrocortisone BP 5 mg (0.5 %)&#44
framycetin sulfate BP 10 mg (equivalent to 7 mg of framycetin base&#45
1%)&#44
dibucaine (cinchocaine) HCl BP 5 mg (0.5%)&#44
and esculin 10 mg (1%) per one suppository unit
Experimental Drug,Active Comparator Drug

Sponsors

Thai Traditional Medicine Research Institute (TMRI), Department for Development of Thai Traditional
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Thailand

Contacts

Public ContactSuporn Charumanee

Faculty of Pharmacy, Chiang Mai University

chsuporn@gmail.com+6682-694- 3996

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026