跳至主要内容
临床试验/CTRI/2025/03/082094
CTRI/2025/03/082094尚未招募1 期

Combined effect of laksha kashayam internally and mukkadi purampada externally in mild to moderate npdr

Sruthi P1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
33
试验地点
1
主要终点
CHANGE IN VISION

研究概览

简要总结

Diabetic retinopathy refers to retinal changes seen in patients with Diabetes mellitus {1}. The underlying pathogenesis of diabetic retinopathy is local vascular endothelial growth factor production initiated by hyperglycemia induced capillary occlusion, which stimulates increased production of retinal vascular endothelial growth factors, increasing capillary permeability, retinal oedema, also stimulating angiogenesis, leading to new vessel formation.{2} The classification used in the Early Treatment Diabetic Retinopathy Study (ETDRS) is widely used internationally which divides it in to Non proliferative diabetic retinopathy(NPDR), proliferative diabetic retinopathy (PDR), Diabetic maculopathy and advanced diabetic eye disease. On the basis of severity NPDR is further classified as mild, moderate, severe and very severe NPDR. Conventionally, the management of mild and moderate NPDR is based on maintenance of control of glycaemia, lifestyle modification along with observation. Severe cases are treated through invasive techniques like intravitreal anti- VEGF drugs, intra vitreal steroids, laser therapy, macular photocoagulation, panretinal photocoagulation and surgical treatment. {3}The pathogenesis of prameha is extensive involving vitiated kapha along with the involvement of dhatus, namely, rasa, mamsa and medas along with kleda,sweda. As the prameha samprapti progresses , involvement of pittha and vata also involves resulting in paitika and vathika meha. {4} The aggrevated doshas,predominantly pitta under the influence of achakhushya nidana enters in to netra through oordwa gami siras and causes disease in different parts of the eye. {5} The global prevalence is 22.27% for diabetic retinopathy among participants with diabetes mellitus 6.17 % for vision threatening diabetic retinopathy and 4.07% for clinically significant macular edema (CSME) .Diabetic retinopathy is considered as the fifth leading cause of blindness.{6} The conventional treatments including anti VEGF are very expensive, invasive , has only poor outcome requires multiple administration within a short interval and risk of complications like endophthalmitis are high.{7} The intervention used in the study are the combination of laksha kashayam internally and mukkadi purampada externally in mild and moderate NPDR which have been clinically practiced in Shalakyatantra OPD of Government Ayurveda College Kannur for a long time. Laksha being a dravya with kashaya rasa, laghu snigda guna, seetha veerya , madhura vipaka . Bidalaka is a procedure where the medicated lepa is applied externally over the eyelids avoiding netra pakshma. The reference of Mukkadi purampada is in Sahasrayoga. The contents are predominantly having seetha veerya and pittaraktahara in nature. Mukkadi bidalaka is specifically mentioned in swelling, burning sensation, pain and congestion stages which makes it a suitable yoga in mild and moderate NPDR. {9

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
35.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1 Participants in the age group 35-70 years, irrespective of gender.
  • 3 Participants with well controlled blood sugar level.
  • (HbA1c less than 7mg/dl) 4 Participants willing to give consent.

排除标准

  • 1 Participants diagnosed with other retinal pathologies.
  • 2 Participants diagnosed with NPDR associated with Chronic kidney disease, Chronic liver disease.
  • 3 Participants with diagnosed with NPDR associated with allergic skin diseases 4 Participants diagnosed with NPDR associated with ulcerative colitis, Crohn’s disease, gastric ulcers.

结局指标

主要结局

CHANGE IN VISION

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

value.

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

moderate NPDR

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

Hard exudates

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

Microaneurysms

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

Dot and blot haemorrhages

时间窗: CHANGE IN VISION | Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score | value. | CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and | moderate NPDR | Hard exudates | Microaneurysms | Dot and blot haemorrhages

次要结局

未报告次要终点

研究者

发起方
Sruthi P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sruthi P

Government Ayurveda College Pariyaram Kannur

研究点 (1)

Loading locations...

相似试验