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CTRI Number  CTRI/2025/08/092766 [Registered on: 11/08/2025] Trial Registered Prospectively
Last Modified On: 08/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   We will see the effect of Nimba and lodhra Araka Aschyotana in vataja abhish shyada We will also see the effect of olapetedine eye drop in vataja abhishyanda with special reference to allergic conjunctivitis  
Scientific Title of Study   A Randomized Controlled Trial of Nimba-Lodhra Arka(eye drop)Aschyotana in Vataja Abhishyanda with special reference to Allergic conjunctivitis.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Muskan Rahim Shaikh 
Designation  B.A.M.S. P.G. scholar 
Affiliation  Government Ayurved College 
Address  OPD no 33,Shalakyatantra department Government Ayurved College and Hospital,Sakkardhara Chowk,Raje Raghuji Nagar,Nagpur-440024,Maharastra,India.

Nagpur
MAHARASHTRA
440024
India 
Phone  7447869986  
Fax    
Email  muskanshaikh3458@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr.Ashok P Vaijwade  
Designation  Associate professor  
Affiliation  Government Ayurved College 
Address  OPD no 33,Shalakyatantra department Government Ayurved College and Hospital,Sakkardhara Chowk,Raje Raghuji Nagar,Nagpur-440024,Maharastra,India.
department Government Ayurved College and Hospital,Sakkardhara Chowk,Raje Raghuji Nagar,Nagpur-440024,Maharastra,India.
Nagpur
MAHARASHTRA
440024
India 
Phone  9421756462  
Fax    
Email  drapvaijwade@gmail.com  
 
Details of Contact Person
Public Query  
Name  Muskan Rahim Shaikh 
Designation  B.A.M.S. P.G. scholar 
Affiliation  Government Ayurved College 
Address  OPD no 33,Shalakyatantra department Government Ayurved College and Hospital,Sakkardhara Chowk,Raje Raghuji Nagar,Nagpur-440024,Maharastra,India.

Nagpur
MAHARASHTRA
440024
India 
Phone  7447869986  
Fax    
Email  muskanshaikh3458@gmail.com  
 
Source of Monetary or Material Support  
Government Ayurved college and Hospital, Sakkardhara Chowk,Nagpur 
 
Primary Sponsor  
Name  Dr Muskan Rahim Shaikh 
Address  OPD no 33 Shalakyatantra Government Ayurved College and Hospital,Sakkardhra Chowk, Nagpur 
Type of Sponsor  Other [self] 
 
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 muskan shaikh  Government ayurvedic hospital   Shalakyatantra OPD no 33 of netravibhag
Nagpur
MAHARASHTRA 		 7447869986

muskanshaikh3458@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute ethics committee   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 ArmDrugClassical(1) Medicine Name: Arka, Reference: Arkaprakash, Route: Topical, Dosage Form: Arka, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 1 Weeks, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Olopetadine eye dropMedicine name-olopetadine 0.1%eye drop Route-topic dose-1drop frequency -bid duration - 1week
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Age 18-60 years
2.with anatomically normal ocular structurrs
 
 
ExclusionCriteria 
Details  Patients suffering from
1.exraocular disease like ptosis,eyelid tumor
2.posterior segment disease
3.traumatic and inflammatory conditions of eye. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To evaluate the efficacy of Nimba-Lodhra Arka Aschyotana in the management of Vataja Abhishyanda with special refrenece to Allergic Conjuctivitis.
2.To evaluate the efficacy of OlopetadineH 0.1% eye drop in the management of Vataja Abhishyanda with special reference to Allergic Conjunctivitis.
3.To comapre effect of Nimba- Lodhra Arka Aschyotana and Olopetadine h 0.1% eye drop in the management of Vataja Abhishynda with special reference to Allergic Conjunctivitis.  		 0th,3rd,5th,7th day of trial 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the concept of Vataja Abhishyanda according ayurvedic line of treatment.
2.To study Allergic Conjunctivitis according to modern point of view.
3.To review and study the literature of Aschyotana in detail. 		 0th,3rd,5th,7th day 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   20/08/2025 
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="6"
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   After clearance of institutional ethics of Government Ayurveda College Nagpur screening of population will be done from patient in OPD and IPD of our institue.
In clinical study 40 each patients in each group of  Allergic Conjunctivitis will be included.
If patients fulfil the criteria of inclusion, subject would also given freedom to ask their questions all questions would answer. 
If he/she agrees for participation in study and found fit to include the patient will include in study.
The treatment will be given to patient as follows :
Group A: 
 Olapetadine Hydrochloride 0.1%

Dose : 1 drop twice a day

Route: Topical

Duration : 7 days

 Group B :
Nimba- Lodhra Arka Asychotana

Dose : 4 drops twice a day

Route: Topical

Duration : 7 days


Study design : Open label Randomized  Controlled Trial.
•Type of RCT : Equivalent clinical trial.
•Type of Recruitment : Parallel group.
•Study setting:  Patients in OPD and IPD of  Shalakyatantra department of our institute.
•Study duration: 18 Months after approval of synopsis.


•Study Population: Patients showing  signs and symptoms of Allergic Conjunctivitis from OPD and IPD of Shalakyatantra department of our institute.

•Randomization -

A Simple  Randomization with computerized generated random samples.

•Sampling method - 

Simple random sampling.

•Study Population: Patients showing  signs and symptoms of Allergic Conjunctivitis from OPD and IPD of Shalakyatantra department of our institute.

•Randomization -

A Simple  Randomization with computerized generated random samples.

•Sampling method - 

Simple random sampling.

•Sample size calculation

It is estimated based on efficacy of  Olopetadine Hydrochloride eye drop in the management of  Vataja  Abhishyanda with special reference to Allergic Conjunctivitis reported in published article.

(Reference :Eiichi Uchio ,Treatment of allergic conjunctivitis with olopatadine hydrochloride eyedro,Clin.Opthalmol. 2008 sep;2(3):525-531) with following assumptions.

Percentage of effectiveness Nimba -Lodhra Arka Aschyotana = 54.5%

Percentage Effectiveness of Olopetadine Hydrochloride 0.2% eye drop = 55%.

      Inclusion criteria                           

1.Patient suffering from Vataja Abhishyanda with special reference to Allergic Conjunctivitis.

2.Patients of age  between 18 years to 60 years will be selected   irrespective of their gender, caste, religion, socioeconomic or educational status.

3. Patients with anatomically normal ocular structures will be selected.

4.Patients who are willing to participate in study and ready to give written consent.

 

Exclusion criteria

 1.Patients with additional infectious or systemic illnesses.

2.Patients suffering from other extra ocular diseases like ptosis, eyelid tumor that blocks the pupil.

3. Patients experiencing disorders of the posterior segment such as sjogren’s syndrome, diabetic retinopathy, hypertensive retinopathy, optic atrophy, macular hole, retinal detachment, glaucoma, and retinal pigmentosa/retinitis.

4.Other traumatic and inflammatory conditions of eye.

Parameter for assessment of study outcomes

The result will be categorized as, -

•Complete relief -- 75% and above.
•Moderate relief -- 50% to 74% improvement
•Mild relief -- 25% to 49% improvement

No relief -- Below 24% improvement.


 
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