| CTRI Number |
CTRI/2025/04/085301 [Registered on: 22/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| 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 Study The Effect OF Dhatri Rasanjan Raskriya Anjan In Pratham Dwitiya Patalgat Timir
|
|
Scientific Title of Study
|
Open Randomised Control Clinical Study Of Dhatri Rasanjan Raskriya Anjan In Pratham Dwitiya Patalgat Timir
|
| 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 Pragati Hemant Murkutey |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Dist Kolhapur |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD no. 5, Kodoli, Dist. kolhapur, Maharashtra
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD no. 5, Kodoli, Dist. kolhapur, Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
7030090606 |
| Fax |
|
| Email |
murkutepragati@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChandrashekhar N Mule |
| Designation |
PG Guide HOD of Shalakyatantra Department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Dist Kolhapur |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD no. 5, Kodoli, Dist. kolhapur, Maharashtra
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD no. 5, Kodoli, Dist. kolhapur, Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrChandrashekhar N Mule |
| Designation |
PG Guide HOD of Shalakyatantra Department |
| Affiliation |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Dist Kolhapur |
| Address |
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD no. 5, Kodoli, Dist. kolhapur, Maharashtra
Yashwant Ayurvedic Medical College PGT and RC Kodoli, Shalakyatantra Department, OPD no. 5, Kodoli, Dist. kolhapur, Maharashtra
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
|
Source of Monetary or Material Support
|
| Daily OPD patients from Yashwant Ayurvedic Medical College PGT and RC Kodoli, Dist. Kolhapur,Maharastra ,India. Pin code 416114 |
|
|
Primary Sponsor
|
| Name |
Dr Pragati Hemant Murkutey |
| Address |
Yashwant Ayurvedic College PGT and RC OPD No.5 Shalakyatantra Department Kodoli Tal Panhala District Kolhapur Maharashtra
India Pin code 416114 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pragati Hemant Murkutey |
Yashwant Dharamartha Rugnalaya Kodoli |
yashwant ayurvedic medical college PGT and RC kodoli OPD no.5 shalakya tantra department
Gondiya
MAHARASHTRA |
7030090606
murkutepragati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Yashwant Ayurvedic Medical College PGT and RC Kodoli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H538||Other visual disturbances. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | anjan | (Procedure Reference: Dr Anant ran sharma sushruta samita of maharsi susruta edited with susrutavinmarsini hindi commentary chaukhamba surbharti prakashan varanasi edition 2008 vol 3 su u 18/64 65 page no 134, Procedure details: anjan can be applied in supine or sitting position. raskriya will avagated in a drop of madhu . eyelids are retracted with left hand & anjan dravya will applied from kanineeka sandhi upto apanga sandhi at the eyelid margin with the help of shalaka.)
(1) Medicine Name: haritkyadi anjan , Reference: Dr indradeva tripathi chakradatta of shri chakrapanidatta with the vaidayaprabha hindi commentry chaukhamba sankrit bhawan varanasi edition reprint 2018 page no 358 netra rog chikitsaadhyay shlok no 109, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 40(mg), Frequency: od, Duration: 8 Days | | 2 | Intervention Arm | Procedure | - | Anjan | (Procedure Reference: Dr. Anant Ram Sharma, shusruta samita of maharshi sushruta edited with susrutavimarsini hindi commentary, chaukhamba surbharati prakashan varanasi edition 2008,vol-3 Su.U. 18/64 page no.-134, Procedure details: the anjan shalaka filled with anjan is held in the right hand to applied from inner to outer or outer to inner side. the left hand is used to stretch the eye.)
(1) Medicine Name: Dhatri Ranjan Raskriya anjan, Reference: vd. harish chandra singh kushwaha, the charak samhita (ayurvedadipika ayushi hindi commentray) 2nd part , publisher- chaukhamba orientalia varanasi reprint -2018, ch.chi.26/260,page no.710, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 40(mg), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having signs and symptoms of pratham patalgat and dwitiya patalgat timir will be included.
Irrespective gender, socioeconomic status, religion. |
|
| ExclusionCriteria |
| Details |
Patients having sign and symptoms of trithiya and chathurtha patalgat timir.
Patient having congenital anomalies of eyes.
Patients with k/c/o any chronic systemic disorder.
Patients having P/H/0 refractive surgery.
Patients who are contraindicated for anjan karma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To decrease sign and symptoms of pratham and twitiya patalgat timir. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To improve vision. |
15 days |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
02/05/2025 |
| 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 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
|
This study is open randomised control study to evaluate the effect of Dhatri Rasanjan Raskriya anjan in Pratham and dwitiya patalagat timir.Patients will be taken from OPD and IPD of the Shalakyatantra Department of Yashwant Ayurvedic Medical College and hospital. The observation will be taken form treatment and at each follow-up assessment result will be A/c to observation and statics analysis. |