跳至主要内容
临床试验/CTRI/2025/04/085057
CTRI/2025/04/085057尚未招募2/3 期

A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Darvi Seka And Rasanjana Pratisarana In The Management Of Krimigranthi With Special Reference To Seborrheic Blepharitis

Dr Pradeepakumara B1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年1月5日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Significant improvement in the signs and symptoms of Krimigranthi

研究概览

简要总结

Krimigranthi is one among Sandhigata Netra Rogas mentioned under Kaphaja Sadhya Vyadhis which affects the Pakshma Vartma Sandhi, Kaneenika Sandhi and Apanga Sandhi. Krimigranthi has symptoms such as Kandu, Granthi, Arthi, Osha, Pakshmashata and Pooyasrava.  The signs and symptoms of Krimigranthi can be clinically analyzed to that of blepharitis. Blepharitis is a subacute or chronic inflammation of lid margin. Prevalence of blepharitis is estimated to be 40% in Indian population.  Seborrheic blepharitis is one of the most frequently encountered eyelid disorder in all age groups, races and genders. It is usually associated with seborrhea of scalp (dandruff) and if untreated it can cause complications like chronic conjunctivitis, recurrent corneal erosion, marginal keratitis and trichiasis, so this should be treated at the earliest. Management of seborrheic blepharitis include general measures like improvement of health, balanced diet and local measures which include removal of scales from the lid margin with the help of luke warm solution of 3% sodium bicarbonate or baby shampoo and frequent application of combined antibiotic and steroid eye ointment at the lid margin.  Long term usage of antibiotic and steroid eye ointment may lead to glaucoma or cataracts. Hence there is a need to find an efficient way in the management of Krimigranthi. Management of Krimigranthi in Ayurvedic classic consists of Swedana, Bhedana and Pratisarana. Darvi which has Tikta - Kashaya Rasa, Laghu - Ruksha Guna and has the properties like Chakshushya, Shothahara, Twakdoshahara and Vranaropaka. Rasanjana Pratisarana – The combination of Rasanjana and Madhu is selected as a trial drug for the present study. Rasanjana is attributed with properties like Tikta - Kashaya Rasa, Laghu - Ruksha Guna which helps to normalise the Raktadhatu and Kaphadosha.   Therefore, in this present study, an effort has been made to evaluate the efficacy of Darvi Seka and Rasanjana Pratisarana in the management of Krimigranthi.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Open Label

入排标准

年龄范围
21.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Subjects aged between 21 to 60 years irrespective of gender, occupation, religion, and socioeconomic status 2.Subjects fulfilling the diagnostic criteria 3.Subjects willing to undergo trial and sign the informed consent.

排除标准

  • 1.Blepharitis associated with psoriasis and any other skin diseases.
  • 2.Diagnosed cases of posterior blepharitis, ulcerative blepharitis, parasitic blepharitis and mixed blepharitis.
  • 3.Patients suffering from chronic ocular infectious conditions like keratitis.
  • 4.Diagnosed cases of uncontrolled systemic diseases which will interfere with the treatment.
  • 5.Pregnant and lactating women.

结局指标

主要结局

Significant improvement in the signs and symptoms of Krimigranthi

时间窗: Pre-assessment-0th day | Post assessment-8th day | 1st Follow up-15th day | 2nd Follow up-30th day

次要结局

  • Generation of in-depth analyzed data on the different aspects of the disease.(Generation of data on possible adverse drug reaction.)

研究者

发起方
Dr Pradeepakumara B
申办方类型
Other [self]

研究点 (1)

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