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CTRI Number  CTRI/2024/04/065246 [Registered on: 05/04/2024] Trial Registered Prospectively
Last Modified On: 04/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Punarnava Arka Standardization and clinical trial in Shushkakshipaka w.s.r.t.Dry Eye Syndrome 
Scientific Title of Study   Development standardization and clinical evaluation of Punarnava Arka in Dry Eye Syndrome w.s.r.t. Shushkakshipaka- Randomized Controlled Clinical Trial 
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 Arunkumar B Biradar 
Designation  Associate Professor 
Affiliation  KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964064955  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arunkumar B Biradar 
Designation  Associate Professor 
Affiliation  KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964064955  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Arunkumar B Biradar 
Designation  Associate Professor 
Affiliation  KAHERs Shri BM Kankanwadi Ayurveda Mahavidyalaya 
Address  KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Shahapur Belagavi

Belgaum
KARNATAKA
590003
India 
Phone  9964064955  
Fax    
Email  arunkumar.biradar@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur BELAGAVI 
 
Primary Sponsor  
Name  KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur, BELAGAVI 
Address  KAHERS Shri BMK Ayurveda Mahavidyalaya, Shahapur, BELAGAVI 
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 Arunkumar B Biradar  KAHERS Shri BMK Ayurveda Mahavidyalaya   Room No. 26 & 27 Department of Shalakyatantra Belgaum KARNATAKA
Belgaum
KARNATAKA 		 9964064955

arunkumar.biradar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Research On Human Subjects  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SUSHKAKSHIPAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Punarnava, Reference: Dr Indradev Tripathi 1995 Arka prakasha of Lankapathi Ravana 1st Edition Varanasi Krishnadas Academy Oriental Publishers and distributers Pg 52 , Route: Ocular, Dosage Form: Arka, Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Sterile eye drops will be dispensed Follow up after 45 days period
2Comparator Arm (Non Ayurveda)-Carboxy Methyl CelluloseEye drop Carboxy Methyl Cellulose 0.5 % one drop 4 times a day for a period of 30 days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Clinical features of DES with reduced quantity and stability of Tear Fluid
2 Age of 18 to 40 years and of either genders
 
 
ExclusionCriteria 
Details  Severe conditions like Steven Johnsons syndrome Chemical Thermal Radiation burns idiopathic atrophy Trachoma Ocular pemphigoid
Corneal epitheliopathies like Neuroparalytic keratitis post herpatic post measles infection of cornea
Conjunctival epitheliopathies like Pterygium Pseudo pterygium Tumours Retention cysts chronic low grade bacterial viral conjunctivitis
Lid abnormalities like Meibominitis Blepharitits Facial nerve palsy Lagophthalmous
Lacrimal gland diseases like infiltration of gland with sarcoidosis lymphoma leukemia and amyloidosis congenital Alacrima
Vitamin A deficiency effect of the drugs like atropine antihistamine diuretics
Specific systemic infections like Tuberculosis Leprosy Hypertension RA Diabetes mellitus etc
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effect of Punarnava Arka in dry eye syndrome  Over a course of 45 days at the follow up period
 
 
Secondary Outcome  
Outcome  TimePoints 
To improve the quality of life by reducing the symptoms  Period of 45 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   01/05/2024 
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  

SUMMARY

Dry eye syndrome (DES), a common ocular condition, arises when the tear film does not adequately support biological functions of the ocular surface. It is having considerable impact on visual function, daily activities, social and physical functioning, workplace productivity, and quality of life. 66% Of Asian population suffering from DES and they experience varying severity of symptoms. Even though Carboxy methyl cellulose 0.5% eye drop has proven to be effective in DES, it is having some adverse effects like Blurring of vision, eye irritation etc. So, in this present study Punarnava Arka Aschotana, a yoga mentioned in Arka Prakasha which is having anti-inflammatory and anti-oxidative properties, has been selected to find an effective and long-standing cure for dry eye syndrome.

RESEARCH PLAN

MATERIALS AND METHODS

DRUG

SANSKRIT NAME

BOTANICAL NAME FAMILY

PART USED

PROPERTIES

Punarnava

Latin Name

Boerhavia diffusa

Family

Nyctaginaceae

Root

Madhura, Tikta, Kashaya

Laghu, Ruksha

Katu Vipaka

Sheeta Virya

Shleshma rakta Pittahara

PREPARATION OF PUNARNAVA ARKA

Sl.

Ingredients

Quantity

01.

Punarnava

1 Parts

02.

Water

35 Parts

 




ANALYTICAL PARAMETERS

Punarnava

·         Physicochemical analysis

·         Microbial limit

Arka

·         Organoleptic parameters

·         pH

·         Specific gravity

·         Microbial load

·         GCMS

·         Sterility study

·         Accelerated Stability study (0,1,3,6 month)


CLINICAL STUDY

Study type                – Interventional

Study site                 – KLE Ayurveda Hospital Shahapur, Belagavi

Study design           – Randomized controlled trial

Groups                      – 2

Sample size             – 30 each

Diagnostic criteria

1.     Reduced quantity of Tear Fluid

2.     Reduced stability of Tear Fluid

Inclusion criteria

Ø  Clinical features of DES with reduced quantity and stability of Tear Fluid

Ø  Age of 18 to 40 years and of either genders

Exclusion criteria

Ø  Severe conditions like Steven Johnson’s syndrome, Chemical-Thermal-Radiation burns, idiopathic atrophy, Trachoma, Ocular pemphigoid

Ø  Corneal epitheliopathies like Neuroparalytic keratitis, post-herpatic / post-measles infection of cornea,

Ø  Conjunctival epitheliopathies like Pterygium, Pseudo-pterygium, Tumours, Retention cysts, chronic low grade bacterial / viral conjunctivitis

Ø  Lid abnormalities like Meibominitis, Blepharitits, Facial nerve palsy, Lagophthalmous,

Ø  Lacrimal gland diseases like infiltration of gland with sarcoidosis, lymphoma, leukemia and amyloidosis, congenital Alacrima

Ø  Vitamin A deficiency, effect of the drugs like atropine, antihistamine, diuretics

Ø  Specific systemic infections like Tuberculosis, Leprosy, Hypertension, RA, Diabetes mellitus, etc.


INTERVENTION

Sample size

Drug

Dose and duration

BT

AT

FU

30

Punarnava Arka

1 drop of Arka 6 times a day for 30 Days

0th day

30th Day

45th day

30

Carboxy methyl cellulose 0.5% Eye drop

1 drop 4 times a day for 30 days

0th day

30th Day

45th day

ASSESSMENT CRITERIA

Subjective parameters

Ø  Feeling of Dryness in Eyes

Objective parameters – BT and AT

Ø  Schirmer’s Test

Ø  Tear Break-up Time

 
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