FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/07/044243 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 05/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   The Effect of Yashtyadi Kwath and Shunthyadi Pindi in the Management of Praklinna Vartma with special reference to Squamous Blepharitis 
Scientific Title of Study   A Clinical Assessment to evaluate the Efficacy of Yashtyadi Kwath and Shunthyadi Pindi in the Management of Praklinna Vartma with special reference to Squamous Blepharitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akash Pralhad Gaikwad 
Designation  PG Scholar 
Affiliation  D Y Patil School Of Ayurveda, Nerul, Navi Mumbai 
Address  Dr. D Y Patil School of Ayurveda, Department of Shalakyatantra, Nerul, Navi Mumbai
Dr. D Y Patil School of Ayurveda, Department of Shalakyatantra, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  97020404747  
Fax    
Email  aakashgaikwad655@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kavita Thorat  
Designation  Associate Professor 
Affiliation  D Y Patil School Of Ayurveda, Nerul, Navi Mumbai 
Address  Dr. D Y Patil School of Ayurveda, Department of Shalakyatantra, Nerul, Navi Mumbai
Dr. D Y Patil School of Ayurveda, Department of Shalakyatantra, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9167219691  
Fax    
Email  kavita.thorat@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Kavita Thorat  
Designation  Associate Professor 
Affiliation  D Y Patil School Of Ayurveda, Nerul, Navi Mumbai 
Address  Dr. D Y Patil School of Ayurveda, Department of Shalakyatantra, Nerul, Navi Mumbai
Dr. D Y Patil School of Ayurveda, Department of Shalakyatantra, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India 
Phone  9167219691  
Fax    
Email  kavita.thorat@dypatil.edu  
 
Source of Monetary or Material Support  
Dr DY Patil school of Ayurveda, Nerul, Navi Mumbai 
 
Primary Sponsor  
Name  Dr Akash Pralhad Gaikwad 
Address  D Y Patil School of Ayurveda and Hospital, D Y Patil Vidyanagar, Sec - 7, Nerul 400706 
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 Akash Pralhad Gaikwad  DY Patil School of Ayurveda  Department of Shalakyatantra, 3rd Floor or 1st Floor OPD no. 4
Thane
MAHARASHTRA 
97020404747

aakashgaikwad655@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:H010||Blepharitis. Ayurveda Condition: PRAKLINNAVARTMA/KAPOTKLISHTA-VARTMA,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Yashtyadi Kwath, Reference: Krishnadas Ayurveda Series 54, Yogaratnakar with ‘Vaidyaprabha’ Hindi commentary by Dr. Indradev Tripathi and Dr. Dayashankar Tripathi., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmProcedure-piNDI, पिण्डी (Procedure Reference: Jaikrishnadas Ayurveda Series No. 58 Sarangdhar Samhita (A treatise on Ayurveda) By Sarangdhar, Translated in English by Ayurvedvidwan Prof. K.R. Srikantha Murthy., Procedure details: Mix all the drugs viz. Shunthi, Nimbapatra and Saindhava with addition of water and cook this mixture till it get thick and attain paste (Kalka) like consistency. Then take a clean cotton cloth and put the lukewarm paste (3-4gm) in the cloth & make pottali of it. Put this for 15-20 mins over both the eyes.)
(1) Medicine Name: Shunthyadi Pindi, Reference: Jaikrishnadas Ayurveda Series No. 58 Sarangdhar Samhita (A treatise on Ayurveda) By Sarangdhar, Translated in English by Ayurvedvidwan Prof. K.R. Srikantha Murthy., Route: Ocular, Dosage Form: Kwatha/Kashaya, Dose: 30(ml), Frequency: bd, Duration: 17 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients presenting with the clinical features of Praklinnavartma (Squamous Blepharitis)
2.Patient with in the age group between 18 to 60 years
3.Patients who are willing to undergo the respective treatment protocol.

 
 
ExclusionCriteria 
Details  Patients who are below 18 years and above 60 years are excluded.
 Pregnant women and lactating mother.
 Patients suffering from other systemic disease like Hypertension, Diabetes Mellitus, Tuberculosis and Asthma.
 Associated with psoriasis and other skin diseases.
 Patients suffering from other ocular disorders like Ptosis, Corneal ulcers, Follicular conjunctivitis, Purulent Conjunctivitis, Trichiasis, Multiple styes, Tumors etc.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the symptoms like Itching, burning, lacrimation, scale formation, congestion & swelling of eyelids  7 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   29/07/2022 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  29/07/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

TITLE OF DISSERTATION

A CLINICAL ASSESSMENT TO EVALUATE THE EFFICACY OF YASHTYADI KWATH AND SHUNTHYADI PINDI IN THE MANAGEMENT OF PRAKLINNA VARTMA WITH SPECIAL REFERENCE TO SQUAMOUS BLEPHARITIS

Aim:To evaluate the efficacy of Yashtyadikwath and ShunthyadiPindi in Praklinnavartma w.s.r to Squamous Blepahritis.

Objectives:

1. To study the etiopathogenesis of Praklinnavartma- Squamous Blepharitits from ayurvedic & modern point of view.

2. To study the effectiveness of YashtyadiKwath and ShunthyadiPindi in Praklinnavartmaw.s.r. to Squamous Blepahritis at both local and systemic levels.

3. To review the relevant literature on Praklinnavartma& Squamous Blepharitits in both Ayurveda & modern perspective.

HYPOTHESIS :-

1. Null Hypothesis H0 :-

There is no effect of Yashtyadi kwath and Shunthyadi Pindi in the management of Praklinnavartma w.s.r. to Squamous Blepahritis.

2. Research Hypothesis H1 :-

There is a significant effect of Yashtyadi kwath and Shunthyadi Pindi in the management of Praklinnavartma w.s.r. to Squamous Blepharitis.

 MATERIAL AND METHODS:

•      Source of data

§   Patient fulfilling the criteria of inclusion will be screened and selected from OPD and IPD of Shalakya Tantra department of D Y Patil School of Ayurveda, Nerul, Navi Mumbai.

§  Method of collection of data  

§  Patients of either sex will be selected based on symptoms of  Praklinnavartma w.s.r. to Squamous Blepharitis

§  Patient willing to participate in the present trial through written informed consent.

Diagnosis will be established on the basis of presence of following signs and symptoms.

1.         Itching in eyes                                                         

2.        Burning sensation in eyes

3.       Pain in eyes

4.        Swelling in eyelids

5.         Lacrimation (Watering from eyes).

6.        Dandruff like deposition (Scales) on eye lid margin.

7.        Through Slit lamp examination - Presence of Scaling on lid margins, Congestion, Oedema of Eyelids.


1) Inclusive criteria -

1. Patients presenting with the clinical features of Praklinnavartma (Squamous Blepharitis)  

2. Patient with in the age group between 18 to 60 years 

3. Patients who are willing to undergo the respective treatment protocol.

2) Exclusive criteria -

1.Patients who are below 18 years and above 60 years are excluded.

2.Pregnant women and lactating mother.

 3.Patients suffering from other systemic disease like Hypertension, Diabetes Mellitus, Tuberculosis and Asthma.Associated with psoriasis and other skin diseases.

4.Patients suffering from other ocular disorders like Ptosis, Corneal ulcers, Follicular conjunctivitis, Purulent Conjunctivitis, Trichiasis, Multiple styes,  Tumors etc.


PINDI KRIYAKALPA :-

v  Kriyakalpa are basically the procedures that are described where medicated Ghee and Churna (powdered formulations) or paste made from churna are administered either directly or indirectly (above or around) the eyes as an effective treatment modality.

v  Pindi is one of the Kriyakalpa described in Sharangdhar Samhita along with Bidalak in addition to other Kriyakalpas viz. Tarpan, Putapaka, Seka, Anjan and Ashchyotan.

v  Pindi is modification of bidalak. in this paste of medicines are covered in a cloth are placed over the closed eyes. it is also called as ‘kavalika’.


 CONTENT:-

NAME

QUANTITY

FORM

Shunthi

2gm

Churna

Nimbapatra

2gm

Churna

Saindhav

1 pinch

Churna


SOP of preparation of Shunthyadi LepaPindi:-

1. Mix all these drugs with addition of water and cook this mixture till it get thick and attain paste (Kalka) like consistency.

2. Then place a clean cloth over both eyes and put the lukewarm paste (3-4gm) over the cloth.

3. Put this for 15-20 mins over the eyes.

 RAS PANCHAKA:-


DRUG

LATIN NAME

RASA

VIRYA

VIPAK

GUNA

KARMA

 

Shunthi

 

Zingiber officinale

 

Katu

 

Ushna

 

Madhura

 

Snigdha, Laghu

Vrishya, Sopha-Kapharuchihara, Vatodara, Swasa, Pandu, SlipadaNasini

 

Nimba

 

Azadirachta indica

 

Tikta, Kashaya

 

Sheeta

 

Katu

 

Ruksha, Laghu

Vranahar, Kushtahara

 

Sainshav

 

Rock salt


Lavana 

 

 

 

 

 

 YASHTYADI KWATH :-

Steps Of Preparation OF YASHTYADI KWATH :-

 Ã¼  Mix all the churna of the following drugs viz. Yashtimadhu, Guduchi, Triphala and Daruharidra in equal quantity.

ü  Prepare a Decoction (Kwath) of these drugs for internal administration.

ü  Drugs which are used are of Rasayana, Tridoshashamak, Netrarogahar, Kandughna, Vedansthapan properties.

Content :- 

Name

Quantity

Form

Yashtimadhu

2gm

Churna

Guduchi

2gm

Churna

Triphala

2gm

Churna

Daruharidra

2gm

Churna

 

RAS PANCHAKA:

DRUG

LATIN NAME

RASA

VIRYA

VIPAK

GUNA

KARMA

 

Yashtimadhu

 

Glycyrrhiza glabra

 

Madhura

 

Sheeta

 

Madhura

 

Guru, Snigdha

Sandhaneeya, Varnya, Kandughna, Shonitasthapana

 

Guduchi

 

Tinospora cordifolia

 

Kashaya, Tikta

 

Ushna

 

Madhura

 

Laghu, Snigdha

Balya, Dahahara, Kushthahara, Krimihara, Chakshushya

 

Triphala

Terminalia chebula

Terminalia bellerica

Emblica officinalis

 

Madhura, Amla, Katu, Tikta, Kashaya

Ushna

Madhura

Ruksha

Sara

Chakshushya, Deepana, Varnaropana, Ruchikara, Medohara

 

Daruharidra

 

Berberis aristata

 

Kashaya, Tikta

 

Ushna

 

Katu

 

Laghu, Ruksha

Arshaghna, Lekshaniya, Kandughna

 

 ASSESMENT CRITERIA :-

 â€¢      An assessment criteria is designed based on subjective parameters :-

 1.      Itching of eyelids (Kandu)

 2.      Burning sensation (Daha)

 3.      Lacrimation (Strav

 4.      Scaling on Lid margin (Klinnata)

 5.      Congestion of lid margin (Raga)

 6.      Lid margin Oedema (Shotha)

 

1)      Itching of eyelids (Kandu) :-

 

0

 

Absent

 

No Itching

 

1

 

Mild

 

Occassional itching sensation

 

2

 

Moderate

 

Intermittent itching sensation which requires rubbing of eye

 

 

3

 

Severe

Most of the time intolerable itching which would requiresignificant eye rubbing

 

 

2)      Burning sensation (Daha) :-

 

 

0

 

Absent

 

No burning sensation

 

 

1

 

Mild

 

Occasional burning sensation

 

 

2

 

Moderate

 

Intermittent burning sensation

 

 

3

 

Severe

Most of the time burning sensation

 

  

3)      Lacrimation (Strav) :-

 

0

 

Absent

 

No lacrimation

 

 

1

 

Mild

 

Occasionally, tear flow out of eyes

 

 

 

2

 

 

Moderate

 

Intermittent out flow of tears 4-5 times / day on exposure to wind or doing some work

 

 

3

 

Severe

 

Most of the time out flow of tears is present

 

 

4)      Scales formation (Klinnata) :-

 

0

 

Absent

 

No Scales formation

 

 

1

 

Mild

 

Small quantity of Whitish material on lid margins

 

 

 

2

 

 

Moderate

 

Moderate quantity of whitish material on lid margins

 

 

3

 

Severe

 

Whitish material lead to sticking of the eyelid margins.

 

 

5)      Congestion of lid margin :-

 

0

 

Absent

 

No Congestion

 

 

1

 

Mild

 

Congestion, visible on slit lamp examination

 

 

 

2

 

 

Moderate

 

Congestion, visible on torch light examination

 

 

3

 

Severe

 

Congestion, visibly evident ondirect inspection

 

 

6)      Lid Margin oedema (Shopha) :- 

 

0

 

Absent

 

No lid margin           oedema

 

 

1

 

Mild

 

Lid margin oedema visible on slit lamp examination

 

 

 

2

 

 

Moderate

 

Lid margin oedema visible on torch light examination

 

 

3

 

Severe

 

Lid margin oedema visibly evident on direct inspection

 


TREATMENT PROTOCOL :-

 

SAMPLE SIZE

 

                       

                         50 PATIENTS

 

 

TREATMENT DAYS

 

 

45 DAYS

 

 

PINDI KRIYAKALPA DAYS

 

 

DAILY FOR 7 DAYS THEN TWICE A WEEK

 

 

KAAL OF THE KRIYAKALPA

 

 

IN THE MORNING

 

 

KWATH

 

YASHTYADI KWATH

 

 

DOSE OF THE KWATH

 

 

30ML

 

KAAL OF THE KWATH

 

 

TWICE A DAY BHOJANOTTAR

 

 

BIBLIOGRAPHY:

1.The Chaukhamba Ayurvijnan Granthamala 71, Sushruta Samhita of Maharshi Sushruta Volume III Edited with ‘Susrutavimarsini’ Hindi Commentary Along with Special Deliberation by Dr. Anant Ram Sharma Foreword by Acharya Priya Vrat Sharma.

2.Krishnadas Ayurveda Series Vol. 27, Vagbhata’sAstangHridayam Translated by Prof. K. R. Srikantha Murthy Volume III UttarSthana.

3.Krishnadas Ayurveda Series 54, Yogaratnakar with ‘Vaidyaprabha’ Hindi commentary by Dr. Indradev Tripathi and Dr. Dayashankar Tripathi.

4.Jaikrishnadas Ayurveda Series No. 58 Sarangdhar Samhita (A treatise on Ayurveda) By Sarangdhar, Translated in English by Ayurvedvidwan Prof. K.R. Srikantha Murthy.

5.Kashi Ayurveda Series 17, Cakradatta (Sanskrit text with English translation), A treatise on Principles and Practices of Ayurvedic Medicine, Edited and Translated by Priya Vrat Sharma.

6.The Chaukhamba Ayurvijnan Granthamala 80, BhaisajyaRatnavali of KavirajGovindadas Sen Edited with ‘Siddhiprada’ Hindi Commentary by Prof. Siddhi Nandan Mishra.

 
Close