Actions of Sinovial in details
Pharmacology: Sinovial is a long acting HMW Sinovial, which, when applied, provides periodontal tissue/fluid balance with accelerated healing and repair functions by preventing the deficiency of natural gingival HMW Sinovial and enhancing its effects.
Sinovial is a naturally occurring physiological constituent of connective tissue (especially in the gingival mucosa), where it performs anti-oedematous and tissue repair functions and does not develop any local or systemic pharmacological effect upon the mucosa.
Sinovial is extensively depolymerized and reduced to its basic subunit constituents by plaque bacterial enzyme action. The physico-chemical and macro-aggregating properties of Sinovial helps to explain its anti-inflammatory properties. It is found in connective tissue throughout the body in a selective and specific manner. It is particularly concentrated in the outmost layers of healthy gingival tissue where it contributes to both the barrier function and tensile strength of the periodontal ligament. The presence of HMW Sinovial is essential for the maintenance of the healthy gingival tissue.
In periodontal disease and other tissue traumas (inflammatory conditions, gingival pockets, wounds), the tissue requirement for Sinovial increases considerably (by up to some 200% compared with the basal values); thus, demonstrating its specific role in regulating cell turnover and optimizing local tissue regeneration.
The deficiency in Sinovial that arises under these conditions prevents the tissue from the following: Restoring the normal free water balance (as a consequence of which swelling and compression causes an increase in pain); activating the migration of fibrocytes (cells contributing to tissue healing) and as a consequence healing is delayed. Therefore, the lack of suitable HMW Sinovial is responsible for the continuation of the inflammatory condition.
Studies in man show that the availability of exogenous Sinovial of similar characteristics to that of the naturally occurring component helps to facilitate the natural tissue healing and recovery process.
Sinovial provides maximum adhesion and thus, allows Sinovial (which would otherwise be eliminated by constant salivary drainage) to remain in situ.
How should I take Sinovial?
This section provides information on the proper use of a number of products that contain hyaluronate sodium. It may not be specific to Sinovial. Please read with care.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For parenteral dosage form (injection):
- For knee pain caused by osteoarthritis:
- Adults—By injection into the knee, 20 milligrams (mg) once a week (one week apart) for a total of five injections.
- Children—Use and dose must be determined by your doctor.
- For knee pain caused by osteoarthritis:
Sinovial administration
Sinovial is injected directly into your knee joint. A healthcare provider will give you this injection.
Sinovial is usually given once every week for 3 to 5 weeks. Follow your doctor's dosing instructions very carefully.
To prevent pain and swelling, your doctor may recommend resting your knee or applying ice for a short time after your injection.
Sinovial pharmacology
Clinical Studies
Study Design
A prospective, double blind, randomized, multi-center clinical study was conducted to evaluate the safety and effectiveness of Sinovial gel when used as a dermal filler in the nasolabial folds. Patients were randomized between Sinovial gel and a commercially available control material, Zyplast implant (derived from bovine collagen) and were injected with enough material to achieve desired correction of each nasolabial fold. (Patients enrolled into the study underwent double bovine collagen skin testing.) At 2 weeks touch-up treatment with additional material was allowed, only if patients showed less than a 1-point improvement on the 6-point grading scale.
The primary efficacy endpoint for the study was the ability to correct nasolabial folds at 12 weeks in comparison to the control material. Correction of nasolabial folds was determined by an independent panel of blinded dermatologists through photographic assessment. Photographs of nasolabial folds were taken prior to treatment and at 3 days, 2, 4, 8, and 12 weeks following treatment. A 6-point grading scale was used to rank wrinkle severity for each photograph in a random, blinded fashion. Additional analyses included the investigator's visual assessment of each patient's nasolabial folds using the 6-point grading scale, and a qualitative assessment of the level of correction by the investigator and by the patient.
Table 2 : Demographics and Pretreatment Characteristics of Total Patient Population, N=261 [Number (% of Patients]
| Gender | Tobacco use | ||
| Male | 16 (6.1) | Non-smoking | 216(82.7) |
| Female | 245 (93.9) | Smokers | 45 (17.2) |
| Ethnicity | Sun Exposure (mean) | 1.6 hrs/day | |
| Caucasian | 208 (79.7) | ||
| African American | 5(1.9) | Patients With Prior Dermal Treatments | 157 (60.1) |
| Asian | 9 (3.4) | ||
| Hispanic | 34(13.0) | ||
| Other | 5(1.9) |
Treatment Material Delivered
The mean total volume injected per nasolabial fold was 0.8 mL for patients in the treatment group (Sinovial gel) and 1.1 mL for patients in the control group (Zyplast implant). The mean volume injected was the same for left and right nasolabial folds and was approximately equivalent to the total volume supplied in one syringe of Sinovial gel (0.75 mL) and of Zyplast implant (1.0 mL) for the clinical study.
Twenty-two (16.5%) of 133 Sinovial patients and 9 (7.1%) of the 128 Zyplast patients required a touch-up treatment. The mean volume injected for touch-up per nasolabial fold was 0.3 mL for Sinovial patients and 0.5 mL for Zyplast patients.
Sinovial Gel Efficacy
Sinovial gel was found to be equivalent to the control materia! (Zyplast implant) in the correction of nasolabial folds after 12 weeks using the independent review of photographs.
Mean Score Based on 6-Point Grading Scale
| Blinded Photographic Assessment | ||
| Pretreatment | 12 Weeks after Treatment | |
| Sinovial | 2.2 | 2.3 |
| Zyplast | 2.3 | 2.2 |
| Grading scale: 0=No wrinkles, 1=Just perceptible wrinkle, 2=Shallow wrinkles, 3=Moderately deep wrinkle, 4=Deep wrinkle, well-defined edges, 5=Very deep wrinkle, redundant fold |
Peak treatment effect with one injection of Sinovial gel was observed during the first 2 weeks after treatment. Photographic assessment showed that, on average, patients had returned to baseline in both groups at 12 weeks. However, the secondary endpoints of investigator's visual assessment and a qualitative assessment of correction by the investigator and by the masked patient during the controlled clinical study support the effectiveness of Sinovial and Zyplast at 12 weeks.
Mean Score Based on 6-Point Grading Scale
| Investigator Live Assessment | ||
| Pretreatment | 12 weeks after treatment | |
| Sinovial | 3.5 | 2.4 |
| Zyplast | 3.5 | 2.3 |
| Grading scale: 0=No wrinkles, 1 =Just perceptible wrinkle, 2=Shallow wrinkles, 3-Moderately deep wrinkle, 4=Deep wrinkle, well-defined edges, 5=Very deep wrinkle, redundant fold |
Based on investigator live assessment, 15% of Sinovial patients and 10% of Zyplast patients returned to pretreatment levels at 12 weeks.
References
- NCIt. "Hyaluronic Acid: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Sinovial are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Sinovial. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported administration
No survey data has been collected yetConsumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
