| CTRI Number |
CTRI/2025/04/085057 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [ ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Evaluate The Action Of Darvi Kashaya Eye Wash And Daru Haridra externally, in the management of eye lid swelling. |
|
Scientific Title of Study
|
A Randomized Open Label Controlled Clinical Study To Evaluate The Efficacy Of Darvi Seka And Rasanjana Pratisarana In The Management Of Krimigranthi With Special Reference To Seborrheic Blepharitis |
| 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 Pradeepakumara B |
| Designation |
Pg Scholar |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Bengaluru |
| Address |
Sri Sri College Of Ayurvedic Science And Research Bengaluru
Department Of Pg Studies in Shalakyatantra Room Number 6 21 st K.M,Kanakapura Road,Udayapura, Bengaluru,Karnataka 560082 India
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9538451727 |
| Fax |
|
| Email |
drpradeepjade.510@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Geetha kumari B |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Bengaluru |
| Address |
Sri Sri College Of Ayurvedic Science And Research Bengaluru
Department Of Pg Studies in Shalakyatantra Room Number 6 21 st K.M,Kanakapura Road,Udayapura, Bengaluru,Karnataka 560082 India
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9480056218 |
| Fax |
|
| Email |
ayurgeeta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha kumari B |
| Designation |
Professor |
| Affiliation |
Sri Sri College Of Ayurvedic Science And Research Bengaluru |
| Address |
Sri Sri College Of Ayurvedic Science And Research Bengaluru
Department Of Pg Studies in Shalakyatantra Room Number 6 21 st K.M,Kanakapura Road,Udayapura, Bengaluru,Karnataka 560082 India
Bangalore Rural
KARNATAKA
560082
India |
| Phone |
9480056218 |
| Fax |
|
| Email |
ayurgeeta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Sri College Of Ayurvedic Science And Research Bengaluru
Department Of Pg Studies in Shalakyatantra Room Number 6 21 st K.M,Kanakapura Road,Udayapura, Bengaluru,Karnataka 560082 India |
|
|
Primary Sponsor
|
| Name |
Dr Pradeepakumara B |
| Address |
Sri Sri College Of Ayurvedic Science And Research Bengaluru
Department Of Pg Studies in Shalakyatantra Room Number 6 21 st K.M,Kanakapura Road,Udayapura, Bengaluru,Karnataka 560082 India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pradeepakumara B |
Sri Sri College Of Ayurvedic Science And Hospital |
Sri Sri College Of Ayurvedic Science And Research Bengaluru
Department Of Pg Studies in Shalakyatantra Room Number 6 21 st K.M,Kanakapura Road,Udayapura, Bengaluru,Karnataka 560082 India
Bangalore Rural
KARNATAKA |
09538451727
drpradeepjade.510@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Sri Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H010||Blepharitis. Ayurveda Condition: SANDHIGATAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sekaH, सेकः followed by pratisarana | (Procedure Reference: sushrutha samhita uttar tantra, Procedure details: Poorva Karma: Eyes will be wiped with cotton soaked in hot water.
Pradhana Karma: Seka will be performed with darvi kashaya by pouring it from 4 angula height for 300 matrakala.
Pashchat Karma:cotton will be dipped in luke warm water to wipe of the remnants.
After 10 minutes rasanjana pratisarana will be done & with the help of cotton soaked in hot water will be used to clean the eyelid. )
(1) Medicine Name: darvi seka, Reference: bhavaprakash nighantu, Route: Ocular, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | sekaH, सेकः followed by pratisarana | (Procedure Reference: sushrutha samhita uttar tantra, Procedure details: Poorva Karma: Eyes will be wiped with cotton soaked in hot water.
Pradhana Karma: Seka will be performed with darvi kashaya by pouring it from 4 angula height for 300 matrakala.
Pashchat Karma:cotton will be dipped in luke warm water to wipe of the remnants.
After 10 minutes Ela pratisarana will be done & with the help of cotton soaked in hot water will be used to clean the eyelid. )
(1) Medicine Name: darvi seka, Reference: bhavaprakash nighantu, Route: Ocular, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged between 21 to 60 years irrespective of gender, occupation, religion, and socioeconomic status
2. Subjects fulfilling the diagnostic criteria
3. Subjects willing to undergo trial and sign the informed consent
|
|
| ExclusionCriteria |
| Details |
1. Blepharitis associated with psoriasis and any other skin diseases.
2. Diagnosed cases of posterior blepharitis, ulcerative blepharitis, parasitic blepharitis and mixed blepharitis.
3. Patients suffering from chronic ocular infectious conditions like keratitis.
4. Diagnosed cases of uncontrolled systemic diseases which will interfere with the treatment.
5. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant improvement in the signs and symptoms of Krimigranthi |
Pre-assessment-0th day
Post assessment-8th day
1st Follow up-15th day
2nd Follow up-30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Generation of in-depth analyzed data on the different aspects of the disease.
Generation of data on possible adverse drug reaction.
|
Pre-assessment-0th day
Post assessment-8th 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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 Applicable |
| 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
|
Krimigranthi is one among Sandhigata Netra Rogas mentioned under Kaphaja Sadhya Vyadhis which affects the Pakshma Vartma Sandhi, Kaneenika Sandhi and Apanga Sandhi. Krimigranthi has symptoms such as Kandu, Granthi, Arthi, Osha, Pakshmashata and Pooyasrava. The signs and symptoms of Krimigranthi can be clinically analyzed to that of blepharitis. Blepharitis is a subacute or chronic inflammation of lid margin. Prevalence of blepharitis is estimated to be 40% in Indian population. Seborrheic blepharitis is one of the most frequently encountered eyelid disorder in all age groups, races and genders. It is usually associated with seborrhea of scalp (dandruff) and if untreated it can cause complications like chronic conjunctivitis, recurrent corneal erosion, marginal keratitis and trichiasis, so this should be treated at the earliest. Management of seborrheic blepharitis include general measures like improvement of health, balanced diet and local measures which include removal of scales from the lid margin with the help of luke warm solution of 3% sodium bicarbonate or baby shampoo and frequent application of combined antibiotic and steroid eye ointment at the lid margin. Long term usage of antibiotic and steroid eye ointment may lead to glaucoma or cataracts. Hence there is a need to find an efficient way in the management of Krimigranthi. Management of Krimigranthi in Ayurvedic classic consists of Swedana, Bhedana and Pratisarana. Darvi which has Tikta - Kashaya Rasa, Laghu - Ruksha Guna and has the properties like Chakshushya, Shothahara, Twakdoshahara and Vranaropaka. Rasanjana Pratisarana – The combination of Rasanjana and Madhu is selected as a trial drug for the present study. Rasanjana is attributed with properties like Tikta - Kashaya Rasa, Laghu - Ruksha Guna which helps to normalise the Raktadhatu and Kaphadosha. Therefore, in this present study, an effort has been made to evaluate the efficacy of Darvi Seka and Rasanjana Pratisarana in the management of Krimigranthi. |