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Interventional, randomised, prospective, monocentric study
Interventional, randomised, prospective, monocentric study
Primary objective :
Demonstrate the interest of the homeopathic Protocol to reduce the onset or aggravation of joint pain as a result of the taking of AI compared to conventional care
Secondary objective :
Compare between the two treatment groups:
Describe in patients receiving homeopathic treatment:
Schedule :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groupe A with homéopathic treatment | Active Comparator | Conventional treatment : paracetamol (drug analgesic class1) + Homeopathic drug : Rhus toxicodendron 9 CH et Ruta graveolens 5 CH |
|
| Groupe B without homeopathic treatment | Sham Comparator | Conventional treatment : paracetamol (drug analgesic class1) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules) | Drug | Rhus toxicodendron 9 CH + Ruta graveolens 5 CH |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of the score of "most intense pain" during the first 3 months of treatment with AI | Evaluation comparing between the 2 groups the area under the most intense pain curve, measured each week during the first 3 months of AI treatment using the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of joint pain | variation of different pain scores on the Brief Pain Inventory-Short Form (BPI-SF) scale (1 no disconfort up to 10 complet disconfort) : pain severity score corresponding to the average of the 4 questions on pain intensity, and interference score corresponding to the average of the 7 questions on the impact of pain | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PHILIPPE GUILBERT | Institut Jean-Godinot | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Philippe GUILBERT | Reims | 51100 | France |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 9, 2026 | |
| Reset | Mar 27, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 9, 2026 | Mar 27, 2026 |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| paracetamol (drug analgesic class1) | Other | paracetamol (drug analgesic class1) |
|
| Rate of onset of joint pain and stiffness | For pain, among patients who answered "no" to the first question of Brief Pain Inventory-Short Form (1 no disconfort up to 10 complet disconfort) to visit 1, percentage of patients who answered "Yes" to 3 months (visit 2) | 3 months |
| Rate of onset of pain and joint stiffness | Percentage of patients for whom pain and / or stiffness have occurred. | 3 months |
| Time of onset or aggravation of pain | time from which the "most severe pain" score has increased for at least 2 consecutive weeks since the Visit 1 score | 6 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |