A RANDOMISED CONTROLLED CLINICAL TRIAL TO STUDY THE ADJUVANT EFFECT OF SHATAVARYADI CHURNA ALONG WITH PHALATRIKADI GHRITA TARPANA IN PRATHAM PATALGATA TIMIRA WITH SPECIAL REFERENCE TO SIMPLE MYOPIA.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study is a randomised controlled clinical, parallel group,open label trial to study the effect of Shatavaryadi Churna along with Phalatrikadi ghrita Tarpana in Pratham Patalgata Timira with special reference to Simple Myopia.
Pratham Patalgata Timira is a disease mentioned in Ayurveda under Drishtigata Netraroga which is caused by vitiated Vata Pitta Dosha according to Ayurveda. It can be co related to Simple Myopia mentioned in modern texts.
It is becoming more common due to factors like excess usage of digital devices, lifestyle changes,etc.
Spectacles offer only temporary relief without addressing the root causes of Simple Myopia. As per Yogaratnakara, Shatavaryadi Churna is a simple oral treatment for Timira with Vata-Pitta shamaka and Chakshushya properties. Sushruta and Vagbhata describe Tarpana as the best therapy for Timira. Hence, Shatavaryadi Churna with Phalatrikadi Ghrita Tarpana may relieve symptoms and slow disease progression.
This is why the topic was selected for further study.
Patient having age group of 18 to 30 years irrespective of gender and occupation and having classical sign and symptoms of Pratham Patalgata Timira will be selected randomly for the present study.
Method of assessment includes Subjective criteria and objective criteria as follows-
Subjective criteria-
1)Indistinct distance vision
2)Eyestrain
3)Headache
Objective criteria-
1)Snellen’s chart for distance vision
2)Autorefractometer
Consent would be obtained from each patient prior to study. Computerised generated Sampling technique will be used.
The total sample size for study will be taken as 50. It will be divided
into two groups as:
Group A as the TRIAL group -Shatavaryadi Churna orally ,3gm, BD for 21 days along with 2 cycles of Phalatrikadi ghrita Tarpana with a gap of seven days in between them .
Group B as the CONTROL group- 2 cycles of Phalatrikadi ghrita Tarpana with a gap of seven days in between them .
Observation of each patient will be done on 0th,7th ,14th ,21st day and follow up on 28th day based on pre designed proforma and assessment criterias for both the groups.
The study would evaluate the impact of Shatavaryadi Churna and Phalatrikadi Ghrita Tarpana on the signs and symptoms of Pratham Patalgata Timira after 21 days of treatment.
Result of study will be drawn on the basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observations and result obtained.Summary will be drawn and conclusion will be drawn on basis of statistical analysis and will be unbiased.
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
- •Patient with symptoms of Pratham Patalagata Timira like Indistinct distant vision, Eye strain, headache.
- •Patient aged 18 to 30 yrs 3)Patient who have less than -3D refractive index in the eyes with normal ophthalmic findings.
排除标准
- •Patient who have symptoms of Dwitiya,Tritiya and Chaturtha Patalagata Timira will be Excluded.
- •Congenital myopia, pathological myopia and acquired or secondary myopia resulting from factors or conditions such as trauma, drug use or post-keratitis will be excluded.
- •Patient who have myopia associated with other refractive errors such as Astigmatism or other ocular diseases like cataract, glaucoma, retinal diseases etc.
- •will be excluded.
- •Patients with a known history of DM, hypertension, rheumatic heart disease, thyroid disorders, asthma, tuberculosis (Koch’s), HIV or with active infectious diseases like viral, fungal, or bacterial conjunctivitis, trachoma or blepharitis.
研究者
Dr Shreya Babaso Kamble
SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403