| CTRI Number |
CTRI/2021/02/031109 [Registered on: 08/02/2021] Trial Registered Prospectively |
| Last Modified On: |
07/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Chakshushya effect of Shigrupatra Ghanvati(Moringa oleifera Lam.) in Simple Myopia. |
|
Scientific Title of Study
|
A Pharmaco-Clinical Study Of Shigrupatra Ghanvati(Moringa oleifera Lam.) As Chakshushya In Timir With Special Reference To 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 |
Dr Khushbu Vinodsinh Desai |
| Designation |
Second Year PG Scholar |
| Affiliation |
PARUL INSTITUTE OF AYURVEDA |
| Address |
Department Of Dravyaguna, Parul Institute Of Ayurved, Parul University, POST- Limda, TAL- Waghodia, Vadodara
Gujarat
391760
India
Department Of Dravyaguna, Parul Institute Of Ayurved, Parul University, POST- Limda, TAL- Waghodia, Vadodara
Gujarat
391760
Vadodara
GUJARAT
391760
India |
| Phone |
8866283284 |
| Fax |
|
| Email |
desaikv_2112@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rekha Parmar |
| Designation |
MD Dravyaguna, HOD |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department Of Dravyaguna, Parul Institute Of Ayurved, Parul University, POST- Limda, TAL- Waghodia, Vadodara
Gujarat
391760
India
Department Of Dravyaguna, Parul Institute Of Ayurved, Parul University, POST- Limda, TAL- Waghodia, Vadodara
Gujarat
391760
Vadodara
GUJARAT
391760
India |
| Phone |
9724306523 |
| Fax |
|
| Email |
rekha.parmar@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rekha Parmar |
| Designation |
MD Dravyaguna, HOD |
| Affiliation |
Parul Institute Of Ayurved |
| Address |
Department Of Dravyaguna, Parul Institute Of Ayurved, Parul University, POST- Limda, TAL- Waghodia, Vadodara
Gujarat
391760
India
Department Of Dravyaguna, Parul Institute Of Ayurved, Parul University, POST- Limda, TAL- Waghodia, Vadodara
Gujarat
391760
Vadodara
GUJARAT
391760
India |
| Phone |
9724306523 |
| Fax |
|
| Email |
rekha.parmar@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute Of Ayurved, Parul University, PO- Limda, TAL- Waghodia, Vadodara 391760
GUJARAT |
|
|
Primary Sponsor
|
| Name |
DR KHUSHBU VINODSINH DESAI |
| Address |
DEPARTMENT OF DRAVYAGUNA, PARUL INSTITUTE OF AYURVEDA, PARUL UNIVERSITY, POST- LIMDA, TAL- WAGHODIA, VADODARA
GUJARAT
391760
INDIA |
| Type of Sponsor |
Other [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 |
| Dr Khushbu Vinodsinh Desai |
Parul Ayurved Hospital |
OPD NO 108, Department Of Shalakyatantra, Parul Ayurved Hospital, Parul University, PO- Limda,TAL- Waghodia 391760
VADODARA
GUJARAT
Vadodara
GUJARAT |
8866283284
desaikv_2112@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIA-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIR, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Shigrupatra Ghanvati |
Shigrupatra Ghanvati will be given in dose of 1 gm orally(2 tablet of 500 mg), three times a day after meal for 45 days. |
| Comparator Agent |
Sugar (Placebo) |
Sugar (Placebo) will be given in dose of 1 gm orally (2 tablet of 500 mg), three times a day after meal for 45 days. |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1)The patients presenting with features of Prathama Patalgata Timir (Simple Myopia) will be selected irrespective of sex, occupation, religion, etc.
2)Patients having dioptric power upto -3.0 D will be included. |
|
| ExclusionCriteria |
| Details |
1)The patients presenting with the features of Dwitiya, Tritiya and Chaturtha Patalgata Timir, High myopia or progressive myopia and congenital myopia will be excluded.
2)Patients having systemic disease like Tuberculosis, Diabetes mellitus, Endocrine disorders, major illness, etc. will be excluded. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sgigrupatra Ghanvati is effective as Chakshushya in Simple Myopia. |
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To validate the Ayurvedic literature. |
90 days |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
08/02/2021 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 inconvenience caused by the refractive aids and surgical complication have made patient seek for medical line of management which is cost effective an easy to follow. The Ayurvedic approach of the disease mainly concentrates on preventing the progression of the disease and also as curative in early stages. A Shigrupatra Ghanvati is a herbal drug, chances of causing any side effect is very less so it is safe to use. Shigru is easily available and used as vegetable in households. It is cost effective. So, a good vision promoter can be found. |