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CTRI Number  CTRI/2024/06/068459 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 31/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To evaluate the efficacy of Lodhra Arka Aschyotana in the management of Kaphaja Abhishyanda. 
Scientific Title of Study   A randomized open-label controlled clinical study to evaluate the efficacy of Lodhra Arka Aschyotana in the management of Kaphaja Abhishyanda. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHARON K MANOHAR 
Designation  PG SCHOLAR 
Affiliation  Sri Sri College of Ayurvedic Science and Research Hospital  
Address  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 KARNATAKA 560082

Bangalore Rural
KARNATAKA
560082
India 
Phone  9497659608  
Fax    
Email  drsharonkm@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveen B S 
Designation  Professor and Head of Deoartment 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 KARNATAKA 560082

Bangalore Rural
KARNATAKA
560082
India 
Phone  09497659608  
Fax    
Email  navs009@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naveen B S 
Designation  Professor and Head of Deoartment 
Affiliation  Sri Sri College of Ayurvedic Science and Research 
Address  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 KARNATAKA 560082

Bangalore Rural
KARNATAKA
560082
India 
Phone  09497659608  
Fax    
Email  navs009@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital 21st km Kanakapura main road Udayapura post Bengaluru Karnataka, 560082, India 
 
Primary Sponsor  
Name  Dr Sharon K Manohar 
Address  Sri Sri College of Ayurvedic Science and research Hospital 21st KM, Kanakapura main road, Udayapura post, Bengaluru 560082  
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 SHARON K MANOHAR  Sri Sri College of Ayurvedic Science and Research Hospital  Room number 305 Department of PG Studies in Shalakyatantra Sri Sri College of Ayurvedic Science and Research Hospital 21st KM Kanakapura main road Udayapura post Bengaluru 560082 Bangalore KARNATAKA
Bangalore Rural
KARNATAKA 		 9497659608

drsharonkm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H109||Unspecified conjunctivitis. Ayurveda Condition: KAPABISHYANDAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: LODHRA ARKA, Reference: ARKA PRAKASA, Route: Ocular, Dosage Form: Arka, Dose: 2(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: SHIGRU PALLAVA ARKA, Reference: ARKA PRAKASA, Route: Ocular, Dosage Form: Arka, Dose: 2(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1.Subjects aged between 21-40 years irrespective of gender, occupation, religion and socio-economic status.
2.Subjects fulfilling the diagnostic criteria.
3.Subjects willing to undergo trial and sign the informed consent.
 
 
ExclusionCriteria 
Details  1.History of any intraocular surgery.
2.Subject having any ocular trauma
3.Diagnosed cases of glaucoma.
4.Subjects having any uncontrolled systemic illness that can interfere with the course of disease and treatment.
5.Subjects suffering from an infective disease of the eye like Uveitis, Scleritis, Keratitis, Stye, Endophthalmitis, Blepharitis,Retinitis, Dacryocystitis.
6.Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant improvement in the signs and symptoms of Kaphaja Abhishyanda.
 		 Pre assessment-0th day
Post assessment-8 th day
1st follow up-15th day
2nd follow up-30th day

 
 
Secondary Outcome  
Outcome  TimePoints 
1.Generation of in depth analysed data on the different aspect of the disease.
2.Generation of data on possible drug reaction.
 		 Pre assessment-0th day
Post assessment-8 th day
1st follow up-15th day
2nd follow up-30th day

 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   15/06/2024 
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="2"
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  

    Kaphaja Abhishyanda is a  Sadhya  Vyadhi  characterized by  Srava, Guruta, Kandu, Shopha and Upadeha.Upon neglecting, it may lead to complications like  Kaphaja Adhimantha.The signs and symptoms of Kaphaja Abhishyanda can be considered to different types of Conjunctivitis which is  broadly  classified into Allergic and Infective.In this present study, an effort will be done to evaluate comparative efficacy of Lodhra Arka Aschyotana in the management of Kaphaja Abhishyanda.

RESEARCH QUESTION:

Whether Lodhra Arka Aschyotana is effective in the management of Kaphaja Abhishyanda?

HYPOTHESES:

Null Hypothesis (H0):There is no significant difference in the efficacy of Lodhra Arka Aschyotana and Shigrupallava Arka Aschyotana in the management of Kaphaja Abhishyanda.

Alternative Hypothesis (H1):The efficacy of Lodhra Arka Aschyotana is better than Shigrupallava Arka Aschyotana in the management of Kaphaja Abhishyanda.

Alternative Hypothesis (H2): The efficacy of Shigrupallava Arka Aschyotana is better than Lodhra Arka Aschyotana in the management of Kaphaja Abhishyanda.
 
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