Trial Outcomes & Findings for Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee (NCT NCT00755326)

Results Overview

‡Pain normalized score and function normalized score are on a scale of 0-10, with 10 indicating extreme pain/difficulty related to knee arthritis and 0 indicating no pain/difficultly related to knee arthritis.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

92 participants

Primary outcome timeframe

8 weeks

Results posted on

2020-01-18

Participant Flow

Recruitment began in April 2007 and ended June 2011.

2-week run-in period of intermediate-dose: 4,000 mg HLXL If no serious adverse events reported after 2 weeks, the high dose (5,600 mg/day) given for 6 additional weeks. Placebo: 14 #0 size gelatin capsules per day, orally, for 8 weeks. Intermediate-dose placebo (2-week run-in) (10 capsules daily) Highest-dose placebo (14 capsules daily)

Participant milestones

Participant milestones
Measure	HLXL Active herb HLXL: Three daily dosages will be investigated. The lowest dosage condition will be 6 capsules (2,400 mg) daily, followed by an escalation to the 10 capsule condition (4,000 mg), and then to the 14 capsule (5,600 mg) condition. Participants will be treated for 6 weeks	Placebo Placebo The placebo was made from a list of FDA approved ingredients/excipient that matched the color and taste of the real HLXL herbal extract, instead of just white powder used in other placebo trials. Same size and color of capsules were used for the placebo and herbal extract. The equivalent number of capsules used in the treatment group at each dose level were administered to patients assigned to the control group.
Overall Study STARTED	47	45
Overall Study COMPLETED	45	42
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	HLXL Active herb HLXL: Three daily dosages will be investigated. The lowest dosage condition will be 6 capsules (2,400 mg) daily, followed by an escalation to the 10 capsule condition (4,000 mg), and then to the 14 capsule (5,600 mg) condition. Participants will be treated for 6 weeks	Placebo Placebo The placebo was made from a list of FDA approved ingredients/excipient that matched the color and taste of the real HLXL herbal extract, instead of just white powder used in other placebo trials. Same size and color of capsules were used for the placebo and herbal extract. The equivalent number of capsules used in the treatment group at each dose level were administered to patients assigned to the control group.
Overall Study Lost to Follow-up	2	3

Baseline Characteristics

Dose Escalation Study Of Chinese Herbs In Osteoarthritis Of The Knee

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HLXL n=47 Participants Active herb HLXL: Two daily dosages will be investigated. The lowest dosage condition will be 10 capsules (4000 mg) daily for the first two weeks to evaluate safety, followed by an escalation to the 14 capsule condition (5,600 mg). Participants will be treated for 8 weeks.	Placebo n=45 Participants Placebo Placebo: Subjects in the placebo group received an equal number of placebo capsule.	Total n=92 Participants Total of all reporting groups
Age, Continuous	60 years STANDARD_DEVIATION 9 • n=39 Participants	60 years STANDARD_DEVIATION 9 • n=41 Participants	60 years STANDARD_DEVIATION 9 • n=35 Participants
Sex: Female, Male Female	32 Participants n=39 Participants	32 Participants n=41 Participants	64 Participants n=35 Participants
Sex: Female, Male Male	15 Participants n=39 Participants	13 Participants n=41 Participants	28 Participants n=35 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Same as baseline.

‡Pain normalized score and function normalized score are on a scale of 0-10, with 10 indicating extreme pain/difficulty related to knee arthritis and 0 indicating no pain/difficultly related to knee arthritis.

Outcome measures

Outcome measures
Measure	HLXL n=47 Participants Active herb HLXL: Two daily dosages will be investigated. The subjects in the HLXL group received the medium dose of HLXL (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/day) for the subsequent 6 weeks.	Placebo n=45 Participants Placebo HLXL Placebo: Subjects in the placebo group received an equal number of placebo capsule.
‡Pain Normalized Score	3.3 Units on a scale Standard Deviation 1.9	2.7 Units on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: 8-Weeks

Population: Same as baseline.

Pain normalized score and function normalized score are on a scale of 0-10, with 10 indicating extreme pain/difficulty related to knee arthritis and 0 indicating no pain/difficultly related to knee arthritis. Overall normalized score is on a scale of 0-30, and is the sum of the pain, stiffness and function normalized scores (each on a scale of 0-10).

Outcome measures

Outcome measures
Measure	HLXL n=46 Participants Active herb HLXL: Two daily dosages will be investigated. The subjects in the HLXL group received the medium dose of HLXL (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/day) for the subsequent 6 weeks.	Placebo n=44 Participants Placebo HLXL Placebo: Subjects in the placebo group received an equal number of placebo capsule.
Function Normalized Score	3.6 Units on a scale Standard Deviation 2.0	2.7 Units on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: 8 weeks

Population: Same as baseline

§Patient Global Assessment is on a scale of 1-5, with 5 indicating excellent and 1 indicating poor (in response to the question "Considering all the ways that your osteoarthritis of the knee affects you, how are you feeling today?")

Outcome measures

Outcome measures
Measure	HLXL n=47 Participants Active herb HLXL: Two daily dosages will be investigated. The subjects in the HLXL group received the medium dose of HLXL (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/day) for the subsequent 6 weeks.	Placebo n=45 Participants Placebo HLXL Placebo: Subjects in the placebo group received an equal number of placebo capsule.
Patient Global Assessment	2.7 Units on a scale Standard Deviation 1.0	2.7 Units on a scale Standard Deviation 1.0

Adverse Events

HLXL

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HLXL n=47 participants at risk Active herb HLXL: Two daily dosages will be investigated. The subjects in the HLXL group received the medium dose of HLXL (10 capsules/day or 4,000mg/day) in the first 2 weeks to evaluate safety. If no adverse effects were observed, the dose was increased to 14 capsules per day (5,600 mg/ day) for the subsequent 6 weeks.	Placebo n=45 participants at risk Placebo HLXL Subjects in the placebo group received an equal number of placebo capsule.
General disorders GI complaint	10.6% 5/47 • Number of events 7 • 8-weeks	11.1% 5/45 • Number of events 6 • 8-weeks

Additional Information

Brian M. Berman

University of Maryland Center for Integrative Medicine

Phone: 410706-6181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place