| CTRI Number |
CTRI/2018/06/014585 [Registered on: 20/06/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/06/2018 |
| 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 see effect of darvi seka and jalaukavcharan in managment of praklinnavartma |
|
Scientific Title of Study
|
ROLE OF DARVISEKA AND JALAUKAVCHARANA IN THE MANAGMENT OF PRAKLINNAVARTMA w.s.r TO ANTERIOR BLEPHARITIS A CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KANCHAN CHAUCHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
rishikul campus haridwar |
| Address |
Rishikul Campus Haridwar Uttarakhand Ayurved University Dehradun
Rishikul Campus Haridwar Uttarakhand Ayurved University Dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568196489 |
| Fax |
|
| Email |
drkanchanchauhan1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KANCHAN CHAUCHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
rishikul campus haridwar |
| Address |
Rishikul Campus Haridwar Uttarakhand Ayurved University Dehradun
Rishikul Campus Haridwar Uttarakhand Ayurved University Dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568196489 |
| Fax |
|
| Email |
drkanchanchauhan1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KANCHAN CHAUCHAN |
| Designation |
PG SCHOLAR |
| Affiliation |
rishikul campus haridwar |
| Address |
Rishikul Campus Haridwar Uttarakhand Ayurved University Dehradun
Rishikul Campus Haridwar Uttarakhand Ayurved University Dehradun
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9568196489 |
| Fax |
|
| Email |
drkanchanchauhan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Registrar Uttarakhand Ayurved University Harrawala Dehradun |
|
|
Primary Sponsor
|
| Name |
Campus Director |
| Address |
Rishikul Campus Haridwar Uttarakhand Ayurved University |
| Type of Sponsor |
Government medical college |
|
|
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 Renu Rao |
Rishikul Campus Hospital |
Shalakya Tantra Department Rishikul Campus Haridwar
Hardwar
UTTARANCHAL |
9358826470
docrenuprasad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients Diagnosed with Praklinnavartma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Darvi Seka
|
Berberis Aristata Mal depuratum
Method Powder of Darvi mixed with 16 time water (1(50gm) part Dravya+16(800ml)part water) and boiled in slow temperature till it become 1/8(100ml) of total amount. The medicated decoction was filtered with the help of cotton so that there should not be any minute particulars in decoction. Then Madhu mixed 1/4 (25gm)in quantity Dose125 gm |
| Comparator Agent |
Jalaukavcharana followed by Darvi Seka |
One sitting of Jalaukavacharana followed by Seka for 7 days (both eye at same day), second sitting of Jalaukavacharana followed by Seka for 7 days (both eyes at same day). (Two sitting of Jalaukavcharana in 15 days at the interval of 7 days followed by Darvi Seka except the day of Jalaukavcharna)
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient presenting with signs and symptoms of Praklinnavartma and anterior Blepharitis.
Age – 10yr-50yr.
Sex – either sex
|
|
| ExclusionCriteria |
| Details |
Patient having diseases like corneal ulcer, dacryocystitis, dry eye, lagophthalmos, infective conjunctivitis etc.
Patients suffering from specific eyelid disorders like ectropion, entropion, trichiasis, tumor, carcinoma, skin allergies.
Systemic diseases like- DM, HTN.
HIV positive patients
Patient having Hb less than 10 gm%
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to study in detail with the prevalence etiopathogenesis clinical features complications of Praklinnavartma (Anterior Blepharitis)and its management By Darvi Seka |
to study in detail with the prevalence etiopathogenesis clinical features complications of Praklinnavartma (Anterior Blepharitis)and its management By Darvi Seka time 15 days of therapy of Darvi Seka and Jalaukavcharana 2 sitting in 15 days therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate clinical efficacy of jalaukavcharana followed by Seka in management of Praklinna vartma (Anterior Blepharitis) |
15 Days |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
06/01/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
Analytical Study of Daruharidra Churna an Ayurvedic Review |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Praklinnavartma (Anterior Blepharitis) is very common Vartmagata disease (inflammation of lid) and chronic in nature its clinical features are Arujam(Painless or mild Pain), Bahay Shunama(lid sollowen lid externally), Antah klinnta(Stickyness), Shrava(Discharge), Kandu(itiching), Nistoda(Foreighn body sensation), if not treated properly trichiasis like complecations occures which causes blindness. Patients selected in to two groups, total 30 patients Group A Darvi Seka Yoga in 15 patients with the duration of 15 days Group B Jalaukavcharana in 2 sittings followed by Darvi Seka in other 15 patients in the duration of 15 days follow up one month
|