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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epiitalis low dose | Active Comparator | Two capsules twice daily 30 mins before meals (breakfast & dinner). |
|
| Epiitalis mid dose | Active Comparator | Two capsules twice daily 30 mins before meals (breakfast & dinner). |
|
| Epiitalis high dose | Active Comparator | Two capsules twice daily 30 mins before meals (breakfast & dinner). |
|
| Placebo | Placebo Comparator | Two capsules twice daily 30 mins before meals (breakfast & dinner). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epiitalis | Other | Two capsules twice daily 30 mins before meals (breakfast & dinner). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as assessed by a SF-36 questionnaire | The 36 Item Short Form Health Survey (SF36) Questionnaire is a set of generic, coherent, and easily administered quality of life measures. These measures rely upon participant self reporting. | 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 |
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Inclusion Criteria:
1. Male & female aged ≥ 40 to ≤ 65 years suffering from primary idiopathic osteoarthritis of the knee diagnosed at least 3 months prior to screening.
2 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.
5 Serum Creatinine & <1.5X UNL. 6 Index knee joint pain rated ≥ 60 on a 100-point Pain-Visual Analogue Scale (VAS).
7. 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.
10. Female participants of childbearing age must be willing to use the accepted methods of contraception during the course of the study.
11. Participants should be willing to be involved in some
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kurla Nursing Home | Mumbai | Maharashtra | 400 070 | India | ||
| Sai Baba Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35732989 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 11, 2022 | |
| Reset | Jun 13, 2022 | |
| Release | Jun 24, 2022 | |
| Reset | Apr 11, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 11, 2022 | Jun 13, 2022 | |||
| Jun 24, 2022 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Placebo | Other | Two capsules twice daily 30 mins before meals (breakfast & dinner). |
|
WOMAC is a widely used questionnaire for Osteoarthritis. WOMAC Index is a tri dimensional self administered questionnaire to assess joint pain, stiffness & physical function. WOMAC Pain comprises of 5 questions related to knee joint pain that score fro 0 to 4 (0 means no pain & 4 means extreme pain). WOMAC Stiffness consists of 2 items (score 0-4, 0 means no stiffness and 4 means extreme stiffness). WOMAC Physical function consists of 17 items with scores 0 to 4 with same scoring pattern. |
| From baseline to 56 days |
| Mumbai |
| Maharashtra |
| 400 074 |
| India |
| Diamond Hospital | Mumbai | Maharashtra | 400064 | India |
| Ayush Nursing Home | Mumbai | Maharashtra | 400067 | India |
| Dinanath Orthopaedic Nursing Home | Mumbai | Maharashtra | 400067 | India |
| K. K. Medical Centre | Mumbai | Maharashtra | 400068 | India |
| Healthcare Medical Center and diagnostics | Mumbai | Maharashtra | 400092 | India |
| Rainbow multispeciality hospital and trauma center | Navi Mumbai | Maharashtra | 400708 | India |
| Apr 11, 2023 |
| D012216 |
| Rheumatic Diseases |