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临床试验/CTRI/2024/10/074834
CTRI/2024/10/074834尚未招募不适用

A Clinical study on the effect of Marichanjana in comparison with Marichanjana along with Vachadi Kashaya internally in Kaphaja Kacha with special reference to Senile Immature Cataract.

Dr V ARCHANA1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
• Slit lamp examination -Lens Opacity Classification System III (LOCS III) grading

研究概览

简要总结

Vision- the ability to see, perceive, interpret and enjoy the surroundings, is one of the greatest assets a human is blessed with. Unfortunately, 94 million people are blind or visually impaired globally and cataract is the most common cause of blindness worldwide. However, most cases of blindness are avoidable.The annual incidence of cataract blindness in India is about 3.8 million. Senile cataract is the most important variant of avoidable blindness.

Cataract refers to development of any opacity in the lens or its capsule. There is no direct mentioning of Senile immature cataract in Ayurveda. However, considering the signs, symptoms and histological changes in the lens, different stages of senile cataract may be compared to kaphaja timira, kacha and linganasha. In Kaphaja Kacha, the persons perceive Sun, Moon and Lamp as lustureless and dull, and Drishti mandala of eye appears as Svetha in color. Thus lakshanas of Kaphaja Kacha can be equated with signs and symptoms of Senile Immature Cataract.

Currently in conventional system of medicine, cataract surgery is the major available treatment. Owing to the increased incidence of senile cataract and possible complications and contra indications of surgery, research for the drugs that could effectively tackle the problem has arisen. Present study aims at evolving an effective measure to tackle this problem by employing Marichanjana explained in the text Basavarajiya by Nellakantakotturu Basavaraja in the chapter named Netra roga nidana lakshana chikitsadaya and Vachadi Kashaya internally described in the text Chikitsa sara sangraha by Vangasena in the chapter named Netra roga adhikara. Marichanjana containing Maricha, Amalaki, Karanja bija and Bringaraja toya are kaphahara and chakshushya. Vachadi kashaya containing Vacha, Trivrit, Chandana, Guduchi, Kirata tikta, Nimba, Haridra and Vasa, are kapha-pitta hara, lekhaniya and chakshushya. Hence, they are effective in kaphaja kacha. Also, they are feasible and affordable. Considering all these facts, the work has been taken up.

HYPOTHESIS:

Null hypothesis:

H0 : Marichanjana and Marichanjana along with Vachadi Kashaya have no significant effect in Kaphaja Kacha.

Alternate hypothesis:

H1 : Marichanjana has better effect than Marichanjana along with Vachadi Kashaya internally in Kaphaja Kacha.

H2 : Marichanjana along with Vachadi Kashaya internally has better effect than Marichanjana alone in kaphaja kacha.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

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

入选标准

  • Patients of age group: 50-70years.
  • Patients of either gender .
  • Patients with classical features of Kaphaja Kacha (Immature cataract) with signs and symptoms like: a)Blurriness of vision b)Glare c)Floaters d)Greyish white :Lens colour e)Iris shadow f)Distant direct ophthalmoscopy with dilated pupil: Multiple dark areas against red fundal glow g)Slit lamp examination: Areas of normal with cataractous cortex.
  • Visual acuity of 6/9 to CF+.

排除标准

  • Senile Mature and Hypermature cataract, Nuclear cataract.
  • Congenital, developmental, traumatic, complicated and metabolic cataract, post surgical cataract etc.
  • Immature cataract associated with systemic diseases (except Controlled Diabetes- HbA1c not more than 7%, Controlled Hypertension).
  • Any other ocular pathology that can cause diminution of vision.
  • Patients contra-indicated for Anjana karma.

结局指标

主要结局

• Slit lamp examination -Lens Opacity Classification System III (LOCS III) grading

时间窗: 60 days

• Visual Acuity grading

时间窗: 60 days

• Blurriness of vision grading

时间窗: 60 days

次要结局

  • • Glare grading(• Floaters grading)

研究者

发起方
Dr V ARCHANA
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Dr V ARCHANA

Government Ayurveda Medical College, Bengaluru

研究点 (1)

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