| CTRI Number |
CTRI/2020/06/025879 [Registered on: 15/06/2020] Trial Registered Prospectively |
| Last Modified On: |
04/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Theraputic] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
use of Rasanjanadi anjana and haridra seka in eyelids infection |
|
Scientific Title of Study
|
CLINICAL STUDY TO EVALUATE THE EFFICACY OF RASAANJANADI ANJAN AND HARIDRA SEKA IN PRAKLINNA VARTMA(Anterior Blepharitis) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi |
| Designation |
Assistant Professor , |
| Affiliation |
Gurukul campus UAU |
| Address |
OPD 8 Dept. of Shalkya Tantra,Uttarakhand Ayurved University,Gurukul Campus,Haridwar
OPD 8,Dept. of Shalkya Tantra,Uttarakhand Ayurved University,Gurukul Campus,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9719353123 |
| Fax |
|
| Email |
docaditi24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aditi |
| Designation |
Assistant Professor |
| Affiliation |
Gurukul campus UAU |
| Address |
OPD 8,Dept. of Shalkya Tantra Uttarakhand Ayurved University ,Gurukul Campus,Haridwar
OPD 8,Dept. of Shalkya Tantra,Uttarakhand Ayurved University, Gurukul Campus ,Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9719353123 |
| Fax |
|
| Email |
docaditi24@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhilasha |
| Designation |
Pg Scholar |
| Affiliation |
Gurukul campus UAU |
| Address |
OPD 8,Dept. of Shalkya Tantra,Uttarakhand Ayurved University ,Gurukul Campus, Haridwar
OPD 8,Dept. of Shalkya Tantra,Uttarakhand Ayurved University ,Gurukul Campus, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8535080272 |
| Fax |
|
| Email |
docabhi53@gmail.com |
|
|
Source of Monetary or Material Support
|
| Registrar,Uttarakhand Ayurved University,Harrawala Dehradun,Uttarakhand,Pin Code:248001 |
|
|
Primary Sponsor
|
| Name |
Gurukul campus UAU Haridwar |
| Address |
Gurukul campus UAU Haridwar |
| 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 Abhilasha |
Gurukul Ayurvedic College,Haridwar |
OPD 8,Shalakaya tantra department,Gurukul campus,UAU, haridwar
Hardwar
UTTARANCHAL |
8535080272
docabhi53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committe, Gurukul Campus |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H010||Blepharitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rasaanjanadi anjana(ointment) along with haridra seka |
20 patient will be given Dose of 3 mg of rasaanjanadi anjana(ointment) + Haridra Seka (Local Application) for 15 days |
| Comparator Agent |
Rasaanjanadi anjana(ointment), Haridra Seka and dietary advices i.e pathya ahara-vihara |
20 patient will be given Dose of 3 mg of rasaanjanadi anjana(ointment) + Haridra Seka (Local Application) for 15 days |
|
|
Inclusion Criteria
|
| Age From |
17.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
person having symptoms of itching, discharge, heaviness in lids, burning sensation, pricking sensation, gluing of cilia, scaling of eyelashes, falling of eyelashes and bulbar congestion. |
|
| ExclusionCriteria |
| Details |
corneal ulcer, entropion, ectropion, Posterior blephritis, dandruff of scalp and eyebrows, uncorrected refractive error, skin disorders, diabetes, hypertension and tumor |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Rasanjanadi Anjana and Haridra Seka in Praklinnvartma(Anterior Blephritis) |
4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Rasanjanadi Anjana and Haridra Seka in Praklinnvartma(Anterior Blephritis) along with dietry advice. |
4 Months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2020 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Praklinnvartma is a very common disease Despite of different treatment modality it is still a challenge to clinicians because of its chronic nature and reoccurance. the contents of the Rasaanjanadi anjan are laghu, ruksha, tikshna, ushna virya and katu vipaka so it will balance kaphaj dosha hence praklinnvartma is a kaphaj netra roga. haridra seka is anti-inflammatory and hence it will also the kapha dosha Total 40 patients will be taken from attached hospital of UAU campus 20 patients will be given anjan +seka 20 patients will be given anjan +seka + dietary advice. |