| CTRI Number |
CTRI/2019/03/018025 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
07/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Panchkarma therapy of Nasya and Tarpan] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic management of Dry eye syndrome |
|
Scientific Title of Study
|
A CLINICO-COMPARATIVE STUDY TO EVALUTE THE EFFICACY OF JIVANTYADI GHRIT TARPAN AND NASYA IN SHUSHKA AKSHIPAKA W.S.R TO DRY EYE SYNDROME |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Deepak Pathak |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 1 Department of Shalakya Tantra Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Patanjali yogpeeth phase 2
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9721907858 |
| Fax |
|
| Email |
drpathak987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Munna Kumar |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 1 Department of Shalakya Tantra Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Patanjali yogpeeth phase 2
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9041249844 |
| Fax |
|
| Email |
kumar_mr27@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Munna Kumar |
| Designation |
Associate Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD no. 1 Department of Shalakya Tantra Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar
Patanjali Yogpeeth Phase 2
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9041249844 |
| Fax |
|
| Email |
kumar_mr27@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Ayurveda Hospital Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar |
|
|
Primary Sponsor
|
| Name |
Patanjali Ayurveda College |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Deepak Pathak |
Block no. 6, Patanjali Yogpeeth, Phase 2, Haridwar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Deepak Pathak |
Patanjali Ayurveda Hospital |
OPD no. 1 Department of Shalakya Tantra Patanjali Ayurvigyan evum Anusandhan Sansthan
Hardwar
UTTARANCHAL |
9721907858
drpathak987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PAC/IEC/2017-18/19 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition: H048||Other disorders of lacrimal system, (3) ICD-10 Condition: H048||Other disorders of lacrimal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effect of Jeevantyadi Ghrita Tarpan in Dry eye syndrome |
Patients will be given Tarpana with Jivantyadi Ghrita for 10 days |
| Comparator Agent |
Effect of Nasya with Jeevantyadi Ghrita in Dry eye syndrome |
Patients will be given Nasya with Jivantyadi Ghrita for 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having clinical features with dry eye and those mentioned in Shushkakshipaka will be included
|
|
| ExclusionCriteria |
| Details |
1. Patients < 18 yrs and > 60 yrs.
2. Patient having complication like acute/chronic infections of lid, conjunctiva, cornea and sclera etc.
3. Patients not willing for registration.
4. Patients with history of ocular trauma.
5. Patients suffering from any systemic/metabolic disorders.
|
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
A) SUBJECTIVE PARAMETERS:
1. Dryness of eyes (Vishushkavata)
2. Foreign body sensation (Gharsha)
3. Burning sensation (paka)
4. Blurred vision (Aaviladarshana)
5. Pain (shula)
6. Photophobia
7. Itching(kandu)
8. Ocular discomfort
B) OBJECTIVE PARAMETERS:
1.Schirmer- I test
2.Flouroscein Tear film break up test (F-TBUT)
3.Rose Bengal staining.
4.Slit lamp examination
|
before intervention of Nasya and Tarpan in Dry-eye patients |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
A) SUBJECTIVE PARAMETERS:
1. Dryness of eyes (Vishushkavata)
2. Foreign body sensation (Gharsha)
3. Burning sensation (paka)
4. Blurred vision (Aaviladarshana)
5. Pain (shula)
6. Photophobia
7. Itching(kandu)
8. Ocular discomfort
B) OBJECTIVE PARAMETERS:
1.Schirmer- I test
2.Flouroscein Tear film break up test (F-TBUT)
3.Rose Bengal staining.
4.Slit lamp examination |
after intervention of Nasya and Tarpan in Dry-eye patients |
|
|
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 |
|
Date of First Enrollment (India)
|
20/03/2019 |
| 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
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this trial, we are selecting the the patients of Dry-eye syndrome in which we will do the intervention in two groups (30 patients in each group). In one group, we will intervene with ayurvedic Therapy of Nasya with Jeevantyadi Ghrita for 10 days whereas in other group, we will intervene with ayurvedic Therapy of Tarpan with Jeevantyadi Ghrita for 10 days. Assessment should be done on the basis of investigations done during pre-treatment and post treatment as discussed earlier. |