Prospective assessment of the efficacy of Astaxanthin-a novel carotenoid anti-oxidant drug as compared to standard anti-oxidant drug(Capsule SM Fibro-lycopene,beta carotene) in the management of Grade I,II and III Oral Submucous Fibrosis patients aged 18 to 60 years: A Double Blind Randomised Controlled Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
研究概览
简要总结
Title : Prospective assessment of the efficacy of astaxanthin-a novel carotenoid anti-oxidant drug as compared to standard anti-oxidant drug (Capsule SM Fibro-lycopene,beta-carotene ) in the management of Grade I,II and III OSMF patients aged 18-60 years: A double- blind ramdomised controlled clinical trial.
OSMF is a highly prevalent disease in the Indian sub-continent with an alarming malignant transformation rate of about 4.2% ,as studied by Kujan O , Mello FW et al in 2021. The etiology being multifactorial , a number of medicinal and surgical approaches have been implemented.The role of oxidative stress in the etio-pathogenesis of this pre-malignant condition has been highlighted in a number of studies with elevated levels of malondialdehyde and 8-hydroxy-20 de-oxyguanosine found in a significant majority of these patients. The promising results obtained with anti-oxidants like lycopene, aloe-vera, curcumin, spirulina and capsules like SM-Fibro, Oxitard, etc have encouraged us to explore the potential of newer carotenoids like H. pluvialis derived super-antioxidant astaxanthin in mitigating the symptoms and intercepting the progress and malignant transformation in OSMF patients. Astaxanthin is also widely regarded for its potent anti-inflammatory, immuno-modulatory role via the transformation growth factor-beta 1 pathway.There is no literature available on the role of astaxanthin in OSMF patients with the only available clinical trial having no follow-up data or histopathological/ biomarker co-relation. In the present study , our primary purpose is to evaluate the efficacy of astaxanthin versus standard anti-oxidant capsule SM Fibro(lycopene, beta-carotene) in the management of GradeI,II and III OSMF patients planned for medicinal management alone. Patients who fulfill the inclusion and exclusion criteria will randomly (based on odd/even OPD no.)be alloted to the study/ control group and various parameters will be evaluated at routine intervals as per the study protocol. Patients in the study group will be treated with astaxanthin 4 mg BD for 3 months while those in the control group will be treated with Capsule SM Fibro(lycopene ,beta-carotene) for 3 months.Both groups will be advised oral physiotherapy and habit cessation too.Both investigator and patients will be meticulously kept blind to the treatment assignment.
The null hypothesis of our study is :
There is no statistically significant difference in the efficacy of Astaxanthin as compared to standard antioxidant drug (Capsule SM Fibro-lycopene, beta-carotene) in the management of Grade I, II and III OSMF patients .
The alternate hypothesis is : There is statistically significant difference in the efficacy of Astaxanthin as compared to standard antioxidant Capsule SM Fibro(lycopene, beta-carotene) in the management of Grade I,II and III OSMF patients.
Various parameters like improvement in trismus,improvement in tongue protrusion, reduction in burning sensation, improvement in cheek flexibility, change in the serum IgA levels, change in the histopathological grading, impact of treatment on quality of life ,etc will be evaluated at the start of study and also at definite intervals .All patients will be kept on 6 month follow-up after treatment completion.
The results obtained in the study will be subjected to appropriate statistical tests and data interpretation will be done and research paper published.
All ethical guidelines related to data collection, informed consent, confidentiality will be strictly adhered to.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18-60 years diagnosed with Grade I,II and III OSMF planned for medicinal management alone.
- •Patient willing to quit betel nut (betel nut and tobacco )quid chewing habit.
- •Patients willing to report for routine follow-up and also to undergo histo-pathological evaluation, blood investigations and continued oral physiotherapy as per the study protocol.
排除标准
- •Patients with Grade IV OSMF indicated for surgery 2)Prior H/O treatment for OSMF, Trauma,burns/sleroderma 3)Pregnant ladies, lactating mothers or those planning to conceive in the next 2 years.
- •Edentulous patients 5)Patients with h/o allergy to sea-food/ astaxanthin, lycopene, beta-carotene, selenium ,minerals,etc.
- •Patients with prior h/o radiotherapy, corticosteroid treatment,cardiovascular,liver or renal disorders 7)Patients with h/o bleeding disorders,auto-immune,diabetics,hypertensives,individuals with low calcium levels,asthmatics,iron metabolic disorders,thyroid disorders 8)Patients with severe obesity, h/o carbamazepine/phenytoin treatment, immuno-supressant,inflammatory bowel disease(due to effect on serum Ig A levels.).
研究者
Dr Janice John
Nair Hospital Dental College ,Mumbai.