| CTRI Number |
CTRI/2026/03/106825 [Registered on: 24/03/2026] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study the effect of Guduchyadi Anjan in people with complaints of Praklinna Vartma (Blepharitis). |
|
Scientific Title of Study
|
RANDOMIZED CONTROL CLINICAL TRIAL TO ASSESS THE EFFICACY OF GUDUCHYADI ANJAN IN THE MANAGEMENT OF PRAKLINNA VARTMA WITH SPECIAL REFERENCE TO 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 Bhagwan Ambadas Mal |
| Designation |
B.A.M.S PG Scholar (Shalakyatantra) |
| Affiliation |
LKR Ayurvedic College and Research Centre |
| Address |
Shalakyatantra OPD, 1st Floor ,LKR Hospital , P2, MIDC area,
Shendri Mal , Gadhinglaj
Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9552848872 |
| Fax |
|
| Email |
bhagwanmal7909@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yuvraj Manohar Sutar |
| Designation |
B.A.M.S.M.S. Shalakyatantra |
| Affiliation |
LKR Ayurvedic College and Research Centre |
| Address |
Shalakyatantra OPD, 1st Floor ,LKR Hospital , P2, MIDC area ,
Shendri Mal , Gadhinglaj
Kolhapur
MAHARASHTRA
416502
India
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9850544418 |
| Fax |
|
| Email |
drsutaryuvrajmsophth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhagwan Ambadas Mal |
| Designation |
B.A.M.S PG Scholar (Shalakyatantra) |
| Affiliation |
LKR Ayurvedic College and Research Centre |
| Address |
Shalakyatantra OPD, 1st Floor ,LKR Hospital , P2, MIDC area,
Shendri Mal , Gadhinglaj
Kolhapur
Kolhapur
MAHARASHTRA
416502
India |
| Phone |
9552848872 |
| Fax |
|
| Email |
bhagwanmal7909@gmail.com |
|
|
Source of Monetary or Material Support
|
| Late Kedari Redekar Ayurvedic College and Research Centre , Gadhinglaj,Kolhapur 416502,india. |
|
|
Primary Sponsor
|
| Name |
Dr Bhagwan Ambadas Mal |
| Address |
At Post Chaigaon,Ta-Mehkar Dist-Buldhana 443301 |
| 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 Bhagwan Ambadas Mal |
LKR Ayurvedic College and Research Centre |
Shalakyatantra OPD,
1st Floor ,LKR
Hospital , P2, MIDC
Area , Shendri Mal ,
Gadhinglaj
Kolhapur,
MAHARASHTRA
Kolhapur
MAHARASHTRA |
9552848872
bhagwanmal7909@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LKREC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H028||Other specified disorders of eyelid. Ayurveda Condition: PRAKLINNAVARTMA/KAPOTKLISHTA-VARTMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guduchyadi Anjan , Reference: Sharangdhar Samhita , Route: Topical, Dosage Form: Varti/ Suppository, Dose: 1(NA), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Azithromycin 1% eye ointment | Azithromycin 1% eye ointment used for 15 days HS 1cm length is applied locally |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having signs and symptoms of Praklinna Vartma as white scales along the eyelashes, Pakshmakandu(Itching), Pakshma Vartma sandhi shotha(EyeLid Swelling), Pakshma Nistod(Pain),Netrastrava (Discharge).
2)Selection will be irrespective of sex, religion and socio
economical class. 3) Paitents of either sex within age group of
18-50yrs.4) Paitents who will give voluntary consent for the study. |
|
| ExclusionCriteria |
| Details |
1)Patient having any other known occular pathology.
2)Any past or present history of occular trauma.
3)Patient with k/c/o NLD Block, Dacrocystitis, DM, HBsAG, HIV.
4)Patient having any contagious disease i.e Conjunctivitis etc.
5)Patient recently undergoes eye surgeries.
6)One eyed patient. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate The Efficacy of Guduchyadi Anjan in Praklinna Vartma W.S.R to Blepharitis. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To Study the Classical literature Praklinna Vartma.
2)To Study Literature related to Blepharitis.
3)To Study Anjan Vidhi in Detail. |
15 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
05/04/2026 |
| 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
|
This study is a Randomized Controlled Clinical Trial to Evaluate the Efficacy of Guduchyadi Anjan in the management of Praklinna Vartma with special reference to Blepharitis. Total 60 patients of age 18 to 50 years of both sex will be randomly selected for this trail and sided into two groups.
Trial A- treated with Guduchyadi Anjan Daily (once a day) over a duration of 15 days Trial B- Treated with Azithromycin 1% eye ointment . Local Application Daily (once a day) over a duration of 15 days
Data will be Analysed and appropriate Statistical tests will be Applied. Result will be presented. |