A Comparative clinical trial on the efficacy of Haridradi anjana and Vrihad panchmooladi eye drops in vataja abhishyanda W.S.R. to simple allergic conjuctivitis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in the number of follicle and diameter of papillae
研究概览
简要总结
INTRODUCTION:-
Today man has achieved high peaks in the field of medicine with the development of various techniques. However, “Ayurveda†the ancient Indian system of medicine, which has its roots in Vedas is still enjoying high profile in serving mankind.
One of the eight branches of Ayurveda, Shalakya Tantra, focuses on the importance of the sense organs or Indriyas in health and sickness. The Shalakya Tantra places a high priority on eye health and examines eye problems in great depths. Acharya Sushrutais the only person who explained the Ophthalmology and E.N.T. in a systemic manner in Uttaratantra portion of his treatise Sushruta Samhita. Again, in this branch, Ophthalmology is having utmost importance because eye is the organ for visual sensation, if only vision is lost, everything is lost. A blind man, though rich cannot enjoy the world. So, to protect this organ is not only a necessity but also a responsibility of every individual.
In Sushruta Samhita four separate chapters have been devoted to the treatment of Abhishyanda after explaining Sarvagata Roga in text. The disease Abhishyanda considerably attracted the ancient physicians, which is evident from their detailed description, classification, symptomatology, complications and management written in Samhitas. Though it has been said that the disease Abhishyanda is a curable entity, but if it takes a chronic course may lead to many associated complications like Vataja Adhimantha, Hatadimantha, Akshipakatyaya, Avranashukla etc.
Acharyas quoted that the same Ahara and Vihara that cause Abhishyanda are the main factors in the majority of eye disorders and it rapidly progresses thus treat it as soon as possible otherwise complications due to Abhishyanda will be severe in nature and difficult to save eyesight.
Vataja Abhishyanda is characterized by Toda (Pricking pain), Sangharsha (foreign body sensation), Achchasruta (watery discharge), Alpa Shopha (mild chemosis), Vishushka Bhava (feeling of dryness), Parushya (dryness)etc which are very similar to the most of signs and symptoms of the simple allergic conjunctivitis. So, Vataja Abhishyanda can be co-related with simple allergic conjunctivitis. (7)
There are six varieties of Allergic Conjunctivitis viz. (3)
· Simple Allergic Conjunctivitis,
· Vernal keratoconjunctivitis (VKC),
· Phlyctenular keratoconjunctivitis (PKC),
· Giant papillaryconjunctivitis (GPC)
· Atopic keratoconjunctivitis
· Contact dermoconjunctivitis (CDC). (AKC) (3)
Simple Allergic Conjunctivitis - Seasonal allergic conjunctivitis (SAC) and perennial allergic conjunctivitis (PAC) are the most common forms of ocular allergies. Estimates vary, but these types of allergy are said to affect at least 15–20% of the population. Allergic conjunctivitis is caused by an allergen-induced inflammatory response in which allergens interact with IgE bound to sensitized mast cells resulting in the clinical ocular allergic expression. The pathogenesis of allergic conjunctivitis is predominantly an IgE-mediated hypersensitivity reaction. Activation of mast cells induces enhanced tear levels of histamine, tryptase, prostaglandins and leukotrienes. These factors initiate the recruitment phase of inflammatory cells in the conjunctival mucosa, which leads to the ocular late-phase reaction.
Diagnostic features of SAC and PAC consist of itching, redness, and swelling of the conjunctiva. Itching is a fairly consistent symptom of SAC and PAC. Modern management include topical antihistamines, mast cell stabilizers, nonsteroidal anti- inflammatory drugs (NSAIDs), and corticosteroids. (4)
NEED AND HYPOTHESIS OF THE STUDY:Simple Allergic Conjunctivitis (Prevalence 5-22% of the general population; Recurrence in 41- 62% cases) is unsolved mystery of modern medicine due to the increased environmental pollution and busy life style. It has an equal distribution more or less throughout the world, without any exception to the developed and under developed countries.
Simple Allergic Conjunctivitis is difficult to treat and is seldom cured, but it may improve. Although serious sequels as a result of corneal involvement are rare, the distressing signs and symptoms may cause extreme discomfort to the patients, it can disturb patients’ routine life.
Now a days, due to busy lifestyle, patients does not have time to think and act for the healthy life and not able to follow the proper instructions for care of the eye, dietetic rules and regulations which may be responsible for the recurrent and relapsing nature of the disease.
General lines of treatment explained in Ayurveda for Abhishyanda are: Langhana, Tikta Anna Sewana, Alepan, Swedana, Siravedhana, Virechana, Anjana and Aschyotana. Among these Anjana and Ashchyotana are simple, safer, most inexpensive procedure, which are indicated in eye diseases. (1)
In Bhaishjya Ratnawali Netrarogadhikar (64/18*)**,* pageno*.*762 , Haridradi Anjana is indicated as Shresth Anjanam for Vataja Abhishyanda. It Contains Haridra, Madhuk, Draksha, and Devdaru PastedinGoat Milk.. As most of the drugs are Vatashamaka in properties So, this formulation is selected for this study.
InYogaratnakar Netraroganamadhikar page no. 387. Under Aschyotana, Vrihad Panchmooladi Aschyotana isindicatedas Aschyotana intheTreatmentof Vataja Abhishyanda. Ingredientsof the Vrihad Panchmooladi Aschyotana Are Bilva, Agnimantha, Shyonaka,, Patala, Gambhari, Erandmoola, Brihati And Madhu Shigru. The drugs having Vatashamaka, Vedanasthapana, Vranaropana and Chakshushya properties may be helpful in the treatment of the disease Vataja Abhishyanda (Simple Allergic Conjunctivitis). But due to some limitations, like time consuming procedure, dose variation, chance of infections due to not following aseptic precaution by the patients, Ashchyotana formulation is not much in practice.
Eye Drops formulation is most common form of topical drug use in ophthalmic practice because standard dose of the eye drops is maintained and patients easily can carry it with them and instill it whenever required by themselves. By keeping this point in mind, eye drops formulation has been selected in present study which can be considered as alternative for Ashtyotana Kriya Kalpa. So, in this study it is planned to compare and evaluate the the efficacy of Haridradi Anjana and Vrihad Panchmooladi eye drops in Vataja Abhishyanda w.s.r. to simple allergic conjunctivitis.
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 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients presenting with signs and symptoms like – 1.Toda (Pricking pain), 2.Stambha (Stiffness of lids), 3.Sangharsha (Foreign body sensation), 4.Parushya (Roughness), 5.Shiroabhitapa(Headache), 6.Vishushka Bhava (Dryness.
- •feeling), 7.Shishirasruta (Cold lacrimation), 8.Achchasruta (clean/ watery discharge), 9.Alpa Shopha (Mild chemosis) 10.Kandu (Itching in eyes) 11.Hyperaemia in palpebral conjunctiva, 12.Swelling in palpebral conjunctiva, 13.Follicle and Papillae in palpebral conjunctiva, 14.Hyperaemia and Chemosis in bulbar conjunctiva.
排除标准
- •1.Patients suffering from other ocular disease such as active uveitis, previous history of ocular glaucoma or condition incompatible with the frequent assessments needed for the study.
- •2.Patients having corneal involvement like marginal corneal ulcer, dacryocystitis, trachoma, keratoconjunctivitis 3.Other types of allergic conjunctivitis like giant papillary conjunctivitis etc., 4.All types of infective conjunctivitis 5.Non-specific systemic infections 6.Patients of ocular trauma 7.Patients having genetic predisposition to allergy.
结局指标
主要结局
Change in the number of follicle and diameter of papillae
时间窗: 0, 28th and 56th day of enrollment
次要结局
- • Change in the symptoms of Toda (Pricking pain), Stambha (Stiffness of lids), Sangharsha (Foreign body sensation), Parushya (Roughness), Shiroabhitapa (Headache), Vishushka Bhava (Dryness - feeling), Shishirasruta (Cold lacrimation), Achchasruta (clean/ watery discharge).(• Change in the itching and hyperemia of Bulbar and palpebral conjunctiva)
研究者
Dr Aayush Soni
National institute of ayurveda jaipur
