Synergistic Effects of Natural Oils and Herbal Extracts on Cholesterol Gallstone Dissolution: In Vitro Comparison With Rowachol®

University of Duhok

Status: Completed

Conditions: Cholesterol Gallstone Dissolution

Treatments: Dietary Supplement: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).; Drug: Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.; Dietary Supplement: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).; Dietary Supplement: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.; Dietary Supplement: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).; Dietary Supplement: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3; Dietary Supplement: Sesame Oil (SO) at 100 mg/mL in dissolving fluid.

Study type: Interventional

Funder types: Other

Identifiers

NCT06972134

AIU-618-11GR (Registry Identifier)

AIU-618-11GR-1358

Details and patient eligibility

About

Objective:

This study aims to evaluate the effectiveness of a natural mixture (sesame oil, extra virgin olive oil, psyllium extract, and dandelion extract) in dissolving cholesterol gallstones compared to the standard medication, Rowachol®.

Methods:

In laboratory experiments, 70 cholesterol gallstones obtained from 55 patients were divided into seven groups. Each group was treated with different combinations of the natural ingredients or Rowachol®. The stones were monitored for 144 hours to measure dissolution rate and cholesterol release.

Enrollment: 55 patients

Sex: All

Ages: 40 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

----------------------------------- Diagnosis of cholesterol gallstones requiring surgical removal. Gallstones with ≥70% cholesterol composition (confirmed via FTIR). Gallstone size: 10-13 mm (measured via digital caliper). Gallstone weight: 120-150 mg (measured via electronic balance). Age range: 40-50 years. BMI: 20-30 kg/m².

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Exclusion criteria

----------------------------------- Hepatitis B/C infection. Chronic or acute illnesses (e.g., liver cirrhosis, hemolytic anemia). Pregnancy or lactation. History of malignancy. Participation in other clinical trials within the past 3 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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55 participants in 7 patient groups

Group 1 (G1)

Experimental group

Description:

Sesame oil (SO) at 100 mg/mL in dissolving fluid.

Treatment:

Dietary Supplement: Sesame Oil (SO) at 100 mg/mL in dissolving fluid.

Group 2 (G2)

Experimental group

Description:

Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.

Treatment:

Dietary Supplement: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.

Group 3 (G3)

Experimental group

Description:

50% Sesame Oil + 50% Extra virgin Olive Oil.

Treatment:

Dietary Supplement: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).

Group 4 (G4)

Experimental group

Description:

50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).

Treatment:

Dietary Supplement: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).

Group 5 (G5)

Experimental group

Description:

: 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).

Treatment:

Dietary Supplement: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3

Group 6 (G6)

Experimental group

Description:

50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil).

Treatment:

Dietary Supplement: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).

Group 7 (G7) - Control

Active Comparator group

Description:

Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.

Treatment:

Drug: Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.