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临床试验/CTRI/2025/08/093479
CTRI/2025/08/093479尚未招募2/3 期

A Randomised clinical study of Vedhana Karma and Akshabeejadi Anjana In Pratham Patalagata Timir.(Myopia -6D)

G J PATEL INSTITUTE OF AYURVEDIC STUDIES RESEARCH1 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2025年9月10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
138
试验地点
1
主要终点
To study the etiopathology of Prathama Patalagata Timir in Ayurveda and Modern. during 3 weeks

研究概览

简要总结

Introduction:

Acharya Sushruta describes six patala in Netra in which 2 Bahya vartma patala and 4 patala in netra - tejo Jalashrita, Pishitashrita, medoashrita, and last Ashtiashrita, dosha enters in 1st and 2nd patala it’s called Timir.

Dalhana described, Tejo-jalashrita patala Teja means alochaka pitta situated in siragata rakta, jala means twachagata rasa dhatu.

According to Acharya Sushruta Timir causing dosha when reach internal orbital organs through the sira and occupies pratahama patala causing blurring of vision, pratahama patalagata timira vitiates the superficial dhatu.

Acharya Sushruta has mentioned Vedhana karma one of the Ashtvidha shastra karma. Here the meaning of Viddha or Vedhana – is to pierce or penetrate something.

Acharya Vagbhat Describe Anjana types, form, matra, kal and according to dosha use of Anjana karma in sutra sthana chapter 23.

For all types of Timir Acharya Vagbhat describe Akshabeejadi Anjana in Uttartantra.

According to a study by NCBI, the prevalence of myopia in India varies between 3.6% and 36.5% depending on the type of study. Population-based studies have a prevalence rate of 3.6% to 36.5%, while school-based studies have a rate of 7.5% to 8.6%, and hospital-based studies have a rate of 9%. Most of these studies include people under the age of 40.

Myopia, commonly referred to as short-sightedness, is the most common eye disease in the world with a substantial social, educational, and economic impact on the affected one.

Simple myopia can be corrected with spectacles or contact lenses, whereas pathological myopia is often associated with potentially blinding conditions such as retinal detachment or macular degeneration.

Origin of the Research Problem:

In modern science, the best option for myopia is wearing glasses or contact lens for myopia.

Another option is LASIK surgery but light sensitivity develops after LASIK surgery complications like Dry eye.

So, we can search for alternative medicine Vedhana karma comparison with Akshabeejadi Anjana and add on effect of Vedhana Karma.

Key Questions:

1. Only Vedhana karma is Effective in Prathama Patalagata Timir (Myopia <-6D)

2. Only Akshabeejadi Anjana is effective in Prathama Patalagata Timir (Myopia <-6D)

3. Add-on effect of Vedhana karma with Akshabeejadi Anjana more effective in Prathama Patalagata Timir (Myopia <-6D)

Hypothesis:

Null hypothesis (H0)

Vedhana karma and Akshabeejadi Anjana have no significant effect in Prathama Patalagata Timir (Myopia <-6D)

Alternative hypothesis (Ha)

Vedhana karma and Akshabeejadi Anjana having significant effect in Prathama Patalagata Timir (Myopia <-6D)

Objectives:

 Primary

1.         To study the etiopathology of Prathama Patalagata Timir in Ayurveda and Modern.

2.         To evaluate the effect of Vedhana Karma in Prathama Patalagata Timir (Myopia -<6D)

Secondary

1.         To evaluate the effect of Akshabeejadi Anjana in Prathama Patalagata Timir (Myopia -<6D)

2.         To evaluate the effect of Vedhana Karma with Akshabeejadi Anjana in Prathama Patalagata Timir (Myopia -<6D).

Research Gap/Review of Literature (International Status/National Status and scope of the proposal):

The treatment of myopia (comparable to Prathama Patalagata Timira) has undesirable aspects such as the permanent use of spectacles.

Akshabeejadi Anjana is one of the effective treatments of Timir.

Vedhana karma, despite being simple and easy to do, remains unexplored in this condition.

Methodology:

Study design - Open Labelled Randomized Comparative Clinical Study.

Group A Vedhana karma

Group B Akshabeejadi Anjana

Group C Vedhana karma & Akshabeejadi Anjana

Sample size total – 138 (Each group 46 Patients Group A 46, Group B 46 and Group C 46)

 Inclusive criteria

Patients with myopia < -6D in at least one eye, diagnosed as per ICD-10-CM Diagnosis Code H52.1 & H52.2 (Simple myopic astigmatism)

Age 18-30 years

Both Gender

 Exclusive criteria

Myopia >-6D

Patient having diseases of Corneal, Choroid, Vitreous, retinal and ciliary muscle

Contraindicated for Vedhana Karma and Anjana

Systemic diseases like DM, Hypertension, Trauma, etc.

Patient is on medication for a blood thinner

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 30.00 Year(s)(—)
性别
All

入选标准

  • Patients with complaints of Prathama Patalagata Timir (Myopia less than -6).

排除标准

  • Patient having diseases of Corneal, Choroid, Vitreous, retinal, and ciliary muscle contraindicated for Vedhana karma and Anjana Systemic diseases like DM, Hypertension, Trauma, etc.
  • Patient is on medication for a blood thinner.

结局指标

主要结局

To study the etiopathology of Prathama Patalagata Timir in Ayurveda and Modern. during 3 weeks

时间窗: Vedhana Karma and Akshabeejadi Anjana is effective in Prathama Patalagata Timir | observ effect of procedure after 3 weeks

To evaluate the effect of Vedhana Karma in Prathama Patalagata Timir (Myopia -6D)

时间窗: Vedhana Karma and Akshabeejadi Anjana is effective in Prathama Patalagata Timir | observ effect of procedure after 3 weeks

次要结局

  • Equally, Effective Anjana and Vedhana Karma in Prathama Patalagata Timir(49 days)

研究者

发起方
G J PATEL INSTITUTE OF AYURVEDIC STUDIES RESEARCH
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dabhi Gautamkumar Pravinsinh

G J Patel Institute of Ayurvedic Study and Research

研究点 (1)

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