| CTRI Number |
CTRI/2025/09/094333 [Registered on: 08/09/2025] Trial Registered Prospectively |
| Last Modified On: |
05/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study of Shatavari Ghrita Aschyotana to See The Effect in Shushkaakshipaka With Special Reference To Dry Eye. |
|
Scientific Title of Study
|
A Randomized, Controlled, Clinical Study of Efficacy of Shatavari Ghrita Aschyotana in Shushkakshipaka With Special Reference To Dry Eye. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VD SWATI SHIVAJI SANAP |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurved College,Nanded |
| Address |
Department of Shalakyatantra Government Ayurved College and Hospital Vazirabad Near kalamandir Chowk Nanded
Government Ayurved College and Hospital Vazirabad Near kalamandir Chowk Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9119566276 |
| Fax |
|
| Email |
swatisanap091@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KALPANA SHAMRAO WAKODE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Ayurved College and Hospital |
| Address |
Shalakyatantra department Government Ayurved College and Hospital Vazirabad Near kalamandir Chowk Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9421757613 |
| Fax |
|
| Email |
kalpanawakode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR KALPANA SHAMRAO WAKODE |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Government Ayurved College and Hospital |
| Address |
Shalakyatantra department Government Ayurved College and Hospital Vazirabad Near kalamandir Chowk Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9421757613 |
| Fax |
|
| Email |
kalpanawakode@gmail.com |
|
|
Source of Monetary or Material Support
|
| self sponsored shalakyatantra Department,Government Ayurved College,Nanded ,Maharashtra 431601 |
|
|
Primary Sponsor
|
| Name |
Vd SWATI SHIVAJI SANAP |
| Address |
Department Of Shalakyatantra Government Ayurvedic College and Hospital Nanded 431601,maharashtra,India |
| Type of Sponsor |
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 |
| DrSWATI SHIVAJI SANAP |
Government Ayurved College and hospital,Nanded 431601 |
Department Of Shalakyatantra ,Government Ayurvedic College and Hospital Nanded 431601
Nanded
MAHARASHTRA |
9119566276
swatisanap091@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Ayurved College and Hospital Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H046||Other changes of lacrimal passages. Ayurveda Condition: SARVAGATAKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: shatavari ghrut, Reference: bhavprakash nighantu, Route: Ocular, Dosage Form: Ghrita, Dose: 2(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: carboxymethylcellulose, Reference: khurana book of opthalm, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient suffering from Dry Eye .
2. Patient of age group 15-60 years.
3. Patient of either gender.
4. Patient willing for treatment
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study role of Shatavari Ghrita Aschyotana in treatment of Shushkakshipaka with special reference to Dry eye. |
14 days assessed on day 7th and day 15th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare efficacy of Shatavarighrita with CMC in Dry eye
2.To avoid the complications of Dry eye |
14 days, assessed on day 7th & day 15th |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
24/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is Randomized controlled clinical Study of effect of shatavarighrita aschyotana in shushkakshipaka with special refference to dry eye in ashyotana form for 14 days in the form of 2 drops QID Per day for 14 days for trial group. Carboxymethylcellulose in same dose for 14 days will be given for control group.this study conducteds as Pg course at single centre.Primary outcome is To study role of Shatavari Ghrita Aschyotana in treatment of Shushkakshipaka with special reference to Dry eye.Outcome of the study will be assessd on following criteria Foreign body sensation and burning sensation in eye will be assesed by using schirmer test before and after treatment |