Randomized Controlled Trial to evaluate the efficacy and safety of Nivarana FastAid oil® in the management of chronic and non healing ulcers
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction in the wound size, antimicrobial activity and changes in the histopathological examination.
研究概览
简要总结
Chronic and non- healing ulcers cause pain, decreased mobility, increased exudates and a limited social life, compromising a person’s health and well-being. This leads to significant disruption, morbidity, and indirect costs to the healthcare and social systems. There has been extensive research in Ayurveda focused on promoting wound healing. The Government of India encourages the conduct of clinical trials to generate evidence for the safety and efficacy of the herbal formulations. These ulcers often resist standard treatments, requiring a more comprehensive approach. Evidence suggests that Nivarana FastAid oil®has strong antimicrobial and anti-inflammatory properties. This makes it beneficial in treating chronic and non – healing ulcers, by minimizing infection and inflammation and accelerating tissue regeneration. Therefore, we wanted to conduct this randomized controlled clinical trial to investigate the efficacy and safety of NivaranaFastAid oil in chronic and non – healing ulcers.
It is a Single centre, Open labelled, Randomized controlled clinical trial.
Study treatments:
Test (T): Standard of care + NivaranaFastAid oil®
Control (C): Standard of care – All routine treatment including surgical intervention, antibiotics, other medications, wound care, topical application, if any and dressing.
Treatment duration: 12 weeks, from randomization to end of study
No. of study participants: Total – 60 patients
| Diabetic ulcer |
30,1:1 randomization
|Venous ulcer
20,1:1 randomization
|Pressure ulcer
10,1:1 randomization
Study procedure:
All the potential participants will undergo a screening procedure (visit 0) after obtaining written informed consent, which includes
i) Clinical screening - demographic information, vital parameters, clinical examination, monofilament test for peripheral neuropathy, ABPI
ii) Diagnostic screening – Complete blood count (CBC), Renal function test (RFT), Liver function test (LFT), Doppler scan, Fasting blood sugar, Postprandial blood sugar and HbA1c.
iii) Wound examination as follows –
· Wound characteristics: physical examination[location, warmth, pain, odour], evidence of infection[erythema, pain, swelling, fluctuance, purulence, and loss of function], surface area[depth, length, and width of the wound], type of tissue[granulation, fibrinous, eschar], wound bed[exposed bones and vessels], exudates[presence, type and amount], wound margins [tunneling, rolled edges, undermining, and fibrotic changes]
· Wound swab for culture and sensitivity
· Histopathological examination.
In the subsequent visit (visit 1 - which will be within 5 days of visit 0), the participants who fulfil the inclusion and exclusion criteria will be enrolled in the study. The participants will be allocated to any one of the treatment arms (T/C) based on randomization. After enrolment in the study, all the participants will receive standard of care as mentioned above and in addition, participants in Test group alone will receive NivaranaFastAid oil® for the duration of 12 weeks.
During visit 1, the investigator will provide wound care including standard of care with or without application of NivaranaFastAid oil® based on randomization. Thereafter the participants will visit the hospital every week (visit 2 to visit 12) during which the investigator will provide wound care based on randomization. In between two successive visits, the participants will do self-care or can visit the hospital for the wound care based on the need and convenience. If the participants have multiple ulcers, the largest ulcer will be taken into consideration for evaluating the treatment efficacy, though treatment will be offered for all the wounds.
In this study, Nivarana FastAid oil® will be applied every day starting from visit 1 to end of study (visit12) in the group which is randomized to receive “T” treatment. The other group will receive daily wound care as per standard of care.
During every visit (visit 1 to 12) the following data will be collected from the participants.
i) Weekly - Vital parameters, clinical examination, ABPI, wound characteristics, safety evaluation (local and systemic adverse events)
ii) Monthly - Fasting blood sugar and Postprandial blood sugar
iii) 12th week (end of study) – Wound swab for culture and sensitivity (In case if the wound is not fully healed), Wound biopsy for histopathological examination (if applicable in case of wounds not completely healed), Complete blood count (CBC), Renal function test (RFT), Liver function test (LFT), Fasting blood sugar, Postprandial blood sugar and HbA1c.
*Renal function test – Urea, Creatinine, Uric acid; Liver function tests: SGOT, SGPT, ALP, GGT, S.Bilirubin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants between 18 and 80 years (both years inclusive), all genders who consent to participate in the study and willing to comply with the protocol requirements.
- •Females of childbearing potential – Negative urine pregnancy test and not breastfeeding and willing to avoid pregnancy during the study period by adopting acceptable method of contraception, such as hormonal methods (pills, patches, injections, implants, vaginal rings), barrier methods (condoms, diaphragms, cervical caps), intrauterine contraceptive devices (IUCDs), and sterilization.
- •Size of the ulcer – Ranging from 0.5 cm2 to 25 cm2
- •Duration of ulcer.
- •3 weeks and more
- •Normal or clinically insignificant deviations of complete blood count, renal function tests and liver function tests
- •Haemoglobin level to be 10g/dl or more for females and 12g/dl or more for males and other genders
- •Ankle Brachial Pressure Index(ABPI).
- •0.8 to 1.
- •Participants.
- •with or without diabetes mellitus or hypertension or peripheral neuropathy
- •The comorbid conditions should be stable and controlled in view of the investigator
- •Ulcer must be of any one of the three types– diabetic ulcer or venous ulcer or pressure ulcer o In case of diabetic ulcer.
- •Grade 1 or 2 of Wagner’s classification and the participants must be diabetic &HbA1c lesser than and equal to 12 percent o In case of venous ulcer.
- •Doppler study showing venous insufficiency and HbA1c less than 9 percent in case of diabetics o In case of Pressure ulcer.
- •Stage II and III as per the National Pressure Ulcer Advisory Panel (2007) classification and HbA1c less than 9 percent in case of diabetics.
排除标准
- •History of hypersensitivity to the study medication(s)
- •Ulcers having mixed etiologies
- •Ulcers with significant cellulitis and/or infection and/or gangrenous features in view of the investigator
- •Ulcers with osteomyelitis and/or exposed bone
- •Histopathology of ulcer showing malignancy
- •Participants with significant and unstable / uncontrolled / severe systemic disorders like cardiovascular, CNS, psychiatry, respiratory, gastrointestinal and renal diseases o Comorbid conditions related to the three types of ulcers included in the study such as diabetes mellitus, venous insufficiency and conditions leading to pressure sores are not excluded
- •Participants with tuberculosis, leprosy, lymphedema, deep venous thrombosis and other pathologies that can result in chronic and non – healing ulcers
- •Participants with systemic sepsis
- •Concomitant medications other than what is required to treat diabetes and/or venous insufficiency and/or pressure ulcer and/or standard of care
- •Any other comorbid conditions that may affect the participants’ safety in view of the investigator.
结局指标
主要结局
Reduction in the wound size, antimicrobial activity and changes in the histopathological examination.
时间窗: Baseline (0), weekly follow-up for 12 weeks
次要结局
- Local and systemic adverse events.
研究者
Arunkumar Radhakrishnan
Chettinad Hospital and Research Institute