Phase 2: Modulation of Gut Microbiota With NBT-NM108 as an Early Treatment for Suspected or Confirmed Symptomatic COVID-19 Patients
This open-label, randomized, and controlled clinical trial aims to determine the feasibility and effectiveness of using NBT-NM108, a novel botanical-based fixed-combination drug, to modulate the gut microbiota and treat early-stage suspected or confirmed symptomatic COVID-19 patients.
Planned Enrollment: 44 participants
Starting date: 11/2021
Ending date: 12/2022
FDA Regulatory Channel
Taken in the form of drinks four times a day (before each main meal and 2 hours after dinner) for 28 days. Each drink is prepared by mixing one sachet (30 g) with 500 ml of water. FDA botanical drug IND
Primary outcome: Gut Microbiota Composition [ Time Frame: Day 0 to 56 ]
Discontinuation of home isolation status
Phase 4: An Investigator Initiated Open-label Study Evaluating the Efficacy and Tolerability of Application of Bodewell Products for the Treatment of Atopic Dermatitis
Estimated Enrollment: 15 participants
Starting Date: 01/2024
Ending Date: 09/2025
FDA Regulatory Channel
Bodewell is a non-prescription and contains 22 botanical ingredients in addition to colloidal oatmeal.
Primary outcome: Mean Percentage improvement in Patient Global Assessment (PGA) [ Time Frame: Baseline to week 12 ]
Secondary outcomes: Percent improvement in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline to week 12 ]
Phase 2: Safety, Tolerability, and Early Efficacy of Oral E-B-FAHF-2 in Subjects With Mild-To-Moderate Crohn's Disease
A randomized, double blind, placebo controlled, parallel assignment phase 2 trial to evaluate the Safety and Tolerability for mild-to-moderate Crohn's Disease (CD) patients over 8 weeks. This is followed by an open-labeled exploratory efficacy extension phase for 6 months.
Planned enroll: 28
Start Date: 02/15/2023
Estimated Completion Date: 05/2025
EBFAHF-2 is a 0.55g capsule that is easy to swallow. The quality, safety and consistency of EBFAHF-2 are established per FDA guidance under a botanical drug title. Low dose (maximum of 2 capsules bid) and full dose (maximum of 5 capsules bid). Weight based dosing will ensure an equivalent amount is given to each individual.
Low dose EBFAHF-2 (29 mg/kg/d divided two times a day) for 2 weeks followed by a full dose (71mg/kg/d divided two times a day) for 6 weeks
Primary Outcomes: Number of grades of adverse events [ Time Frame: 8 months ]
Number of participants requiring an escalation in therapy. [ Time Frame: 6 months ]
Fecal Calprotectin [ Time Frame: 6 months ]
PROMIS Profile 29 [ Time Frame: 6 months ]
Self Efficacy Scale: IBDSES [ Time Frame: 6 months ]
Immunologic Changes in PBMC cytokine levels [ Time Frame: 6 months ]
Phase 3: Safety and Efficacy of T89 in the Prevention and Treatment of Adults With Acute Mountain Sickness (AMS)
Previous clinical studies showed T89 has substantial benefits in the prevention or amelioration of symptoms associated with acute mountain sickness (AMS).This is double-blind, randomized, placebo controlled pivotal phase 3 study. After informed consent is obtained, eligible subjects will be randomized to one of the 3 study groups (T89 high dose, T89 low dose and placebo control). The study drug will be given orally for 5 days (2 days at sea level and 3 days at high altitude). The clinical assessment of Lake Louise Scoring System (LLSS), blood oxygen saturation, the exercise tolerance, blood pressure and heart rate will be performed at sea level and altitude. A total of 846 subjects will be enrolled with 282 subjects in each treatment arm, and a minimum of 756 subjects are expected to complete the study.
Planned Enrollment: 846 participants
Starting Date: 07/21/2021
Ending Date: 04/2024
T89 capsule is a modernized industrialized version of a traditional Chinese herbal medicine, containing 75mg active substance which is the water extract of Danshen and Sanqi.
Primary outcomes: Change of baseline corrected mean LLSS score on Day 4 morning (next mornings after arrival at high altitude) between T89 and placebo groups. [ Time Frame: Baseline and day 4 ]
The change of blood oxygen saturation levels (SpO2) at high altitude between T89 and placebo groups. [ Time Frame: Baseline and days 3-6 ]
The change of the area under the curve (AUC) of baseline corrected LLSS score-time profile between T89 and placebo groups. [ Time Frame: Baseline and days 3-6 ]
The change in total incidence of LLSS score ≥5 on Day 4 morning between T89 and placebo groups. [ Time Frame: Day 4 morning ]
The change of percentage reduction of the daily total LLSS score from Day 4 to Day 5 between T89 and placebo groups. [ Time Frame: Days 4-5 ]
he change of baseline corrected LLSS score at any given time points between T89 and placebo groups. [ Time Frame: Baseline and days 3-6 ]
Phase 2: Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria
The main purpose of this study is to investigate the feasibility of a follow-up larger RCT on the efficacy of Botanical Tincture to relieve abdominal pain in people with Irritable Bowel Syndrome Constipation Predominant (IBS-C).
Planned Enrollment: 60 participants
Starting Date: Dec 2023
Ending Date: Jan 2025
herb tincture at 12ml/dose daily, under FDA Botanical Drug IND category
Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain) [ Time Frame: 12 week study ]
Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe) [ Time Frame: 12 week study ]
Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week [ Time Frame: 12 week study ]
Phase 1: Efficacy of a Botanical Supplement to Provide Period Relief
In this study, two products that are used to alleviate period pain will be examined. One test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. The trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. Participants will use the botanical product alongside a traditional over-the-counter period product during their second period. Participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial.
Planned Enrollment: 100 participants
Starting Date: 02/8/2023
Ending Date: 07/01/2023
Participants will take 450mg of Pamprin Botanicals two days before their predicted period and then take it every day during their period. Under the US FDA botanical drug IND
Primary outcome: Changes in common menstrual cycle symptoms [Time Frame: 2 menstrual cycles (approximately 60 days)] [ Time Frame: 60 days ]
Secondary outcomes: Changes in blood biomarkers during the menstrual cycle [Time Frame: 2 menstrual cycles (approximately 60 days)] [ Time Frame: 60 days ]
Phase 2: Investigating The Combination Of YIV-906 And Sorafenib (Nexavar®) In HBV (+) Patients With Advanced Hepatocellular Carcinoma
The aim of this study is to compare the efficacy and safety of YIV-906 plus standard-of-care sorafenib versus those of sorafenib alone as a first-line systemic treatment for patients with Hepatitis B (+) associated advanced hepatocellular carcinoma. YIV-906 (PHY906, KD018) is an immune system modulator. Clinical and preclinical research suggests that YIV-906 could act to enhance the body's immune response to fight cancer and increase the anti-tumor activity of sorafenib and protect and repair the gastrointestinal tract by reducing inflammation and promoting tissue regeneration. Patients in the study arm will be treated orally each 28-day course with YIV-906 (600 mg (3 capsules) BID) + sorafenib (400 mg BID) according to the following schedule: sorafenib BID daily treatment for 28 days, and YIV-906 BID 4 days on and 3 days off weekly in each course. All patients will be evaluated and graded for adverse events according to the NCI Common Terminology for Adverse Events, version 5.0 (CTCAE). The Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) will be used to establish disease response or progression. The RECIST 1.1 and mRECIST will be used in a blinded independent central review (BICR) to determine the study endpoints. Patients will be evaluated for PFS, TTP, OS, antitumor response every two cycles, and QoL and safety at the beginning of each cycle. Biomarkers are mandatory and will be studied prior to drug administration on day 1 of each cycle. TCM Syndrome Research is optional. PK is only applicable in China study sites and limited to the first 15 male and 15 female patients. Patients will be randomized to either the study drug arm or the placebo arm (2:1 ratio). PK studied immediately prior to dose administration and at 1 hour, 2 hours, 4 hours, and 12 hours post-dose administration on Day 1 of Cycles 1.
Planned Enrollment: 125 participants
Starting Date: 01/10/2020
Ending Date: 12/31/2023
YIV-906 is a botanical drug candidate, composed of an extract of four herbs and administered in oral capsule form.
Primary Outcomes: Progression free survival (PFS) [ Time Frame: At baseline, then at the end of every two cycle (i.e. approximately every 8 weeks), until disease progression or discontinuation from study. Assessed up to 24 months.
Time to progression (TTP) [ Time Frame: At baseline, then at the end of every two cycle (i.e. approximately every 8 weeks), until disease progression or discontinuation from study. Assessed up to 24 months. ]TTP is defined as the period elapsing between the date of randomization and the date of disease progression.
Overall survival (OS) [ Time Frame: at randomization, then at the end of every two cycle (i.e. approximately every 8 weeks), until death from any cause. Assessed up to 24 months. ]OS is defined as the interval between time of randomization and the date of death from any cause.
Objective response rate (ORR) in each arm [ Time Frame: At baseline, then at the end of every two cycle (i.e. approximately every 8 weeks), until disease progression or discontinuation from study. Assessed up to 24 months. ]The Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) will be used to establish disease response or progression
Disease control rate (DCR) in each arm [ Time Frame: At baseline, then at the end of every two cycle (i.e. approximately every 8 weeks), until disease progression or discontinuation from study. Assessed up to 24 months. ]DCR will be defined as the proportion of patients achieving either partial response (PR) or complete response (CR) or stable disease (SD).
The safety and tolerability of the combination of YIV-906 plus sorafenib as measured by the rate and severity of AEs [ Time Frame: Continuously throughout the study until 28 days after treatment discontinuation ]All patients will be evaluated and graded for adverse events according to the NCI Common Terminology for Adverse Events, version 5.0 (CTCAE).
Change of quality of life (QoL) in each arm with HCC18 [ Time Frame: At the beginning of every course (4 weeks) until the end of study. Assessed up to 24 months. ]Each of the domains in the HCC18 will be scored per the assessment's scoring algorithm and summarized using descriptive statistics at baseline