| CTRI Number |
CTRI/2022/01/039398 [Registered on: 13/01/2022] Trial Registered Prospectively |
| Last Modified On: |
07/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study held to see the effect of chitrakadi kwath in the management of pratham patalagata timir (simple myopia) |
|
Scientific Title of Study
|
A single arm clinical study to evulate the efficacy of chitrakadi kwath in the management of pratham patalagata timir (simple myopia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kiran Sinhmar |
| Designation |
MS Scholar Shalakya |
| Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre |
| Address |
Department of shalakya opd no 6 ground floor Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Department of shalakya opd no 6 ground floor Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9813589210 |
| Fax |
|
| Email |
kiransinhmar91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Jagtap |
| Designation |
Associate Professor |
| Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre |
| Address |
Department of shalakya opd no 6 ground floor Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Department of shalakya opd no 6 ground floor Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
8983535924 |
| Fax |
|
| Email |
pallavibhor78@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kiran Sinhmar |
| Designation |
MS Scholar Shalakya |
| Affiliation |
Dr D Y Patil college of Ayurveda and Research Centre |
| Address |
Department of shalakya opd no 6 ground floor Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Department of shalakya opd no 6 ground floor Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018
Pune
MAHARASHTRA
411018
India |
| Phone |
9813589210 |
| Fax |
|
| Email |
kiransinhmar91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurveda and Research Centre |
|
|
Primary Sponsor
|
| Name |
Kiran Sinhmar |
| Address |
Dr D Y Patil college of Ayurveda and Research centre Sant Tukaram Nagar Pimpri Pune |
| 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 |
| Kiran Sinhmar |
Dr D Y Patil College of Ayurveda and Research Centre |
Shalakaya OPD and IPD Dr D Y Patil college of Ayurveda and Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra
Pune
MAHARASHTRA |
9813589210
kiransinhmar91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H531||Subjective visual disturbances. Ayurveda Condition: PRATHAM PATALAGATA TIMIRAH , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chitrakadi kwath, Reference: Yogratnakar Netraroga adhikar 1, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -goghrita), Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)All the patients presenting with sign and symptoms of pratham patalagata timir will be taken for clinical trials of either caste, religion, socioeconomic status
2)Individuals of either sex of age group between 18 to 40 years
3)Patients having myopia upto 5.0D ( Spherical)
4)Patients who are ready to sign informed concent form |
|
| ExclusionCriteria |
| Details |
1)Patients having other type of myopia
2)Patient having cataract and post operative cataract
3)Any inflammatory and traumatic conditions of eyes
4)Pregnant and lactating women
5)Myopia with systamic disease like TB,Hypertension, Diabetes Mellitus
6)Patients having more than -5D of refractive power
7)Patient who need surgical and other interventions
8)Patients with other eyes disease like glucoma(increased risk IOP), sceritis,conjunctivitis
9)History of genetic problems |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy of chitarkadi kwath on distant visual acuity and refractive power of the myopic patients. |
30 days study with 2 follow ups (0,15,31 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
26/03/2022 |
| Date of Study Completion (India) |
30/12/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The aim of study is to see the effectiveness of chitrakadi kwath in management of pratham patalagata timir (simple myopia). The study will be conducted with 30 patients showing signs and symptoms of pratham patalagata timir ( simple myopia) they will be administered chitrakadi kwath with goghrita once in a night for 30 days and follow up will be done on 15 and 31 days and conclusion will be drawn on the basis on proper statistical methods. |