NCT04117490

Brief Summary

Epiitalis is an ingredient of a currently marketed product named as Osteo-Restore, indicated for joint health.The present study is primarily planned to establish the role of Epiitalis as a single ingredient in the treatment of mild to moderate cases of knee Osteoarthritis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
Last Updated

February 1, 2022

Status Verified

November 1, 2020

Enrollment Period

10 months

First QC Date

October 3, 2019

Last Update Submit

January 31, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Effect of consumption of IP on knee joint pain as assessed by the change in the 100-point Visual Analogue Scale (VAS) from baseline and when compared with the placebo.

    Participant's assessment of pain will be done on a 100 mm Visual Analogue Scale (Pain), where 0 means no pain and 100 means unbearable pain.

    From baseline to 56 days

Secondary Outcomes (2)

  • Quality of life as assessed by a SF-36 questionnaire

    From baseline to 56 days

  • Effect of IP consumption and the placebo on Knee joint pain, Knee joint stiffness & Knee joint function as assessed by a specific questionnaire

    From baseline to 56 days

Study Arms (4)

Epiitalis low dose

ACTIVE COMPARATOR

Two capsules twice daily 30 mins before meals (breakfast \& dinner).

Other: Epiitalis

Epiitalis mid dose

ACTIVE COMPARATOR

Two capsules twice daily 30 mins before meals (breakfast \& dinner).

Other: Epiitalis

Epiitalis high dose

ACTIVE COMPARATOR

Two capsules twice daily 30 mins before meals (breakfast \& dinner).

Other: Epiitalis

Placebo

PLACEBO COMPARATOR

Two capsules twice daily 30 mins before meals (breakfast \& dinner).

Other: Placebo

Interventions

EpiitalisOTHER

Two capsules twice daily 30 mins before meals (breakfast \& dinner).

Epiitalis high doseEpiitalis low doseEpiitalis mid dose
PlaceboOTHER

Two capsules twice daily 30 mins before meals (breakfast \& dinner).

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male \& female aged ≥ 40 to ≤ 65 years suffering from primary idiopathic osteoarthritis of the knee diagnosed at least 3 months prior to screening.
  • BMI ≥ 18 and ≤ 29.9 kg/m2. 3 Fasting blood sugar ≤ 126 mg/dl 4 LFT: Serum Glutamic oxaloacetic transaminase (SGOT) \& \<2X Upper Limit of Normal (UNL) and Serum Glutamic-Pyruvic transaminase (SGPT) \& \<2X UNL.
  • Serum Creatinine \& \<1.5X UNL. 6 Index knee joint pain rated ≥ 60 on a 100-point Pain-Visual Analogue Scale (VAS).
  • \. Osteoarthritis grade II/ III (Kellgren-Lawrence classification) as confirmed by: Grade II - Definite osteophytes and possible joint space narrowing (JSN) on the anteroposterior weight-bearing radiograph Grade III - Multiple osteophytes, definite JSN, sclerosis, and possible bony deformity 8. Systolic blood pressure \& \<140 mmHg and diastolic blood pressure \& \< 90 mmHg 9. In the case of hypothyroidism, only euthyroid patients will be allowed to be screened further. Blood reports of last 3 months will be valid at the time of screening.
  • \. Female participants of childbearing age must be willing to use the accepted methods of contraception during the course of the study.
  • \. Participants should be willing to be involved in some

You may not qualify if:

  • History of osteoarthritis for more than 3 years.
  • History of osteoporosis and/or frequent fractures.
  • History of major trauma to the index joint.
  • History of arthroscopic surgery or intervention on the index joint or awaiting a replacement of knee or hip joint.
  • History of restless leg syndrome.
  • Participants who have received intra-articular steroids or hyaluronic acid within the last three months.
  • Not willing to abstain from the use of NSAIDs (including low dose aspirin 50 mg/day for cardiovascular health) or herbal/ nutraceutical supplements for joint health.
  • Not willing to abstain from application of local analgesics, herbal oil 48 hours prior to study visit.
  • Use of any immunosuppressive drugs in the last 12 months (including steroids).
  • Participants with deformity of the knee joint.
  • Participants categorized as ACR Functional Class I osteoarthritis
  • Participants who are significantly incapacitated or disabled and would be categorized as ACR Functional Class IV osteoarthritis (largely or wholly incapacitated), or unable to walk without assistive devices.
  • Participants with other known rheumatic or inflammatory diseases such as rheumatoid arthritis, osteomyelitis, and bone metastasis.
  • Current smokers or chronic alcoholics.
  • History of bleeding disorders.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Kurla Nursing Home

Mumbai, Maharashtra, 400 070, India

Location

Sai Baba Hospital

Mumbai, Maharashtra, 400 074, India

Location

Diamond Hospital

Mumbai, Maharashtra, 400064, India

Location

Ayush Nursing Home

Mumbai, Maharashtra, 400067, India

Location

Dinanath Orthopaedic Nursing Home

Mumbai, Maharashtra, 400067, India

Location

K. K. Medical Centre

Mumbai, Maharashtra, 400068, India

Location

Healthcare Medical Center and diagnostics

Mumbai, Maharashtra, 400092, India

Location

Rainbow multispeciality hospital and trauma center

Navi Mumbai, Maharashtra, 400708, India

Location

Related Publications (1)

  • Mitchell PG, Bright CA, Bright DR, Srivastava SN, Raote SS, Kumar S. The Biota orientalis, oil extract Epiitalis(R), is efficacious at reducing the symptoms of knee osteoarthritis: a pilot, multi-site, dose-ranging, randomized, blinded, placebo-controlled trial. Inflammopharmacology. 2022 Aug;30(4):1323-1334. doi: 10.1007/s10787-022-01013-y. Epub 2022 Jun 22.

    PMID: 35732989DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2019

First Posted

October 7, 2019

Study Start

December 12, 2019

Primary Completion

October 21, 2020

Study Completion

October 21, 2020

Last Updated

February 1, 2022

Record last verified: 2020-11

Locations

IN(8)