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CTRI Number  CTRI/2024/07/070722 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Anjana karma and aschyotana]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison in efficacy of anjana and eye drops in allergic conjuctivitis 
Scientific Title of Study   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. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aayush Soni 
Designation  PG scholar 
Affiliation  National institute of ayurveda jaipur 
Address  Room no 313 National institute of ayurveda jaipur 302002
Jorawar singh gate
Jaipur
RAJASTHAN
302002
India 
Phone  9166399918  
Fax    
Email  soni.ayush9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Rajendra Soni 
Designation  Assistant Professor 
Affiliation  National institute of ayurveda jaipur 
Address  Room no 306 National institute of ayurveda jaipur 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9455067007  
Fax    
Email  vaidya.rajsoni@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aayush Soni 
Designation  PG scholar 
Affiliation  National institute of ayurveda jaipur 
Address  Room no 311 National institute of ayurveda jaipur 302002

Jaipur
RAJASTHAN
302002
India 
Phone  9166399918  
Fax    
Email  soni.ayush9@gmail.com  
 
Source of Monetary or Material Support  
National institute of ayurveda,deemed to be university jaipur 302002  
 
Primary Sponsor  
Name  National institute of ayurveda jaipur 
Address  National institute of ayurveda jorawar singh gate jaipur 302002 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aayush soni  National institute of ayurveda jaipur  Room number 14 shalakya tantra opd nia hospital block jaipur
Jaipur
RAJASTHAN 
9166399918

soni.ayush9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA JAIPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H102||Other acute conjunctivitis. Ayurveda Condition: ABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-a~jjanam, अंजनम् (Procedure Reference: Bhaishjya Ratnawali/Netrarogadhikar/18, Procedure details: Anjana preparation will be in ointment form & will be applied from nasal canthus to temporal canthus in 60 mg dose divided in two doses in both eyes till watering and irritation subsides followed by eye wash with distilled water.)
(1) Medicine Name: Haridradi Anjana, Reference: Bhaishjya Ratnawali/Netrarogadhikar/18, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 60(mg), Frequency: bd, Duration: 28 Days
2Comparator ArmProcedure-AScyotanam, आश्च्योतनम् (Procedure Reference: Yogaratnakar/Netrarogadhikar/Aschyotan/1, Procedure details: drops will be instilled directly into the eyes followed by moping with sterile cotton)
(1) Medicine Name: vrihad panchmooladi eye drops, Reference: Yogaratnakar/Netrarogadhikar/Aschyotan/1, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Duration: 28 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in the number of follicle and diameter of papillae   0, 28th and 56th day of enrollment 
 
Secondary Outcome  
Outcome  TimePoints 
• 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

 
0, 28th and 56th day of enrollment 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   12/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

    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 Sushruta is 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), page no.762 , Haridradi Anjana is indicated as Shresth Anjanam for Vataja Abhishyanda. It Contains Haridra, Madhuk, Draksha, and Devdaru Pasted   in Goat Milk.. As most of the drugs are Vatashamaka in properties So, this formulation is selected for this study.

 In Yogaratnakar Netraroganamadhikar page no. 387. Under Aschyotana, Vrihad Panchmooladi Aschyotana is  indicated as Aschyotana in the Treatment of Vataja Abhishyanda. Ingredients of 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.

 
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