| CTRI Number |
CTRI/2020/03/024341 [Registered on: 30/03/2020] Trial Registered Prospectively |
| Last Modified On: |
27/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study On The Effect Of Tiktaka Ghrita Tarpana,Prasadana Putapaka, Kataka Khadiradi Ghana Vati In Diabetic Retinopathy |
|
Scientific Title of Study
|
A Randomized Open Label Clinical Trial On the efficacy of Tiktaka Ghrita Tarpana, Prasadana Putapaka And Kataka Khadiradi Ghan Vati In Madumehajanya Timira With Special Reference To Diabetic Retinopathy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Shamsa Fiaz |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No 309,
Department of Shalakya Tantra,
National Institute of Ayurveda,
Jorawar Singh Gate,
Amer Road,
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shamsa Fiaz |
| Designation |
Professor and Head of the Department |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No 309,
Department of Shalakya Tantra,
National Institute of Ayurveda,
Jorawar Singh Gate,
Amer Road,
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K S S P Fernando |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda |
| Address |
Room No 312,
Department of Shalakya Tantra,
National Institute of Ayurveda,
Jorawar Singh Gate,
Amer Road,
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9351248532 |
| Fax |
|
| Email |
shivanthipalikaks@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Director, National Institute of Ayurveda, Jorawar Singh Gate,
Amer Road,
Jaipur |
|
|
Primary Sponsor
|
| Name |
Director National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Jorawar Singh Gate,
Amer Road,
Jaipur |
| 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 K S S P Fernando |
National Institute of Ayurveda |
OPD No 14, Department of Shalakya Tantra, National Institute of Ayurveda,Jorawar Singh gate, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN |
9351248532
shivanthipalikaks@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ataka Khadiradi Ghan Vati 500 mg twice daily with Tiktaka Ghritha Tarpana (Group B) |
This group will be treated with oral medication Kataka Khadiradi Ghan Vati 500 mg twice daily orally before food for 30 days along with Tiktaka Ghritha Tarpana (Local Treatment) for 7 days(Trial group2). |
| Intervention |
Kataka Khadiradi Ghan Vati 500 mg twice daily orally (Group A) |
This group will be treated with oral medication of Kataka Khadiradi Ghan Vati 500 mg twice daily orally before food for 30 days.
(Trial Group 1). |
| Comparator Agent |
Kataka Khadiradi Ghan Vati 500 mg twice daily orally with Tiktaka Ghritha Tarpana (Local Treatment) and Prasadana Putapaka (local treatment) (Group C) |
This group will be treated with oral medication Kataka Khadiradi Ghan Vati 500 mg twice daily orally with Tiktaka Ghritha Tarpana (Local Treatment) for 7 days and Prasadana Putapaka (local treatment)for 3 days (Trial group 3). |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Known cases of Type I and Type II diabetes mellitus
2. Patients with well controlled blood sugar level
3. Patients with visual symptoms like blurring of vision, floaters etc
4. Patients with mild to moderate NPDR
5. Patients willing to give written consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with severe NPDR or with PDR, Diabetic Maculopathy.
2. Patients with Diabetic Retinopathy with complications like Retinal detachment, posterior vitreal detachment, acute vitreal hemorrhage, RubiosisIridis.
3. Gestational Diabetic Retinopathy.
4. Severe visual impairments like high Myopia, Retinitis Pigmentosa, mature Cataract, post Cataract surgeries, Glaucoma.
5. Patients with other systemic complaints like Hypertension, Renal impairment, COPD, cardiovascular diseases. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Diabetic Retinopathy signs and symptoms as Blurred vision, Floaters and etc |
2 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Procedures might show effect in headache, other eye problems such as Dry eye, Occular Stress, Concretions hence any associated incidental findings if found will be reported. |
2 month |
|
|
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 2 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| 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="0"
Months="6"
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
|
This trial will be done to evaluate clinical efficacy of Kataka Khadiradi kashaya which has mentioned for all types of Prameha. In order to make it palatable and easy to administer the same kashaya is made in the form of Ghan vati in the dose of 500 mg orally to control madhumeha which is the primary disease. Hence in one group only oral medicine, Kataka Khadiradi Ghan Vati is advised to prove the efficacy of oral therapy The second group will be given Kataka Khadiradi Ghan Vati along with Tarpana a local treatment with Tiktaka Ghrita. Third group will be given Kataka Khadiradi Ghan Vati along with Tarpana a local treatment with Tiktaka Ghrita and Prasadana Putapaka to show the significant effect of KriyaKalpa procedures. 1 month research and 1 month follow up after treatment will be done within 15 days gap |