| CTRI Number |
CTRI/2024/09/073388 [Registered on: 04/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of Shigru Patra Netrabindu and Goghrita Ashchyotan in Shushkakshipaka with special reference to Dry Eye Disease |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Shigru Patra Netrabindu and Goghrita Ashchyotan in the management of Shushkakshipaka w.s.r. to Dry Eye Disease |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranjali Dubey |
| Designation |
PG Scholar |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor room no. 2, Department of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
6263771292 |
| Fax |
|
| Email |
pranjalid1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shubhangi Lohakare |
| Designation |
Associate Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor room no. 2, Department of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462042
India |
| Phone |
9890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shubhangi Lohakare |
| Designation |
Associate Professor |
| Affiliation |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor room no. 2, Department of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya Pradesh
MADHYA PRADESH
462042
India |
| Phone |
9890698452 |
| Fax |
|
| Email |
shindeshubh84@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
|
|
Primary Sponsor
|
| Name |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
| Address |
Fourth Floor room no. 2, Department of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre Hinotiya Alam Kolar road Bhopal Madhya Pradesh |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranjali Dubey |
Mansarovar Ayurvedic Medical College Hospital and Research Centre |
Fourth Floor room no. 2, Department of Shalakya Tantra, Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH |
6263771292
pranjalid1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee Mansarovar Ayurvedic Medical College Hospital and Research Centre Bhopal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: Sharangdhar Samhita Uttarakhand , Procedure details: Shigru Patra Netrabindu Ashchyotan will be given 10 drops once a day for 15 days)
(1) Medicine Name: Shigru Patra Netrabindu , Reference: Bhavprakash Nighantu Guduchyadi Varga, Route: Topical, Dosage Form: Arka, Dose: 10(drops), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: Sharangdhar Samhita Uttarakhand , Procedure details: Goghrita Ashchyotan will be given 10 drops once a day for 15 days)
(1) Medicine Name: Goghrita, Reference: Sushruta Samhita Sutrasthan, Route: Topical, Dosage Form: Ghrita, Dose: 10(drops), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having sign and symptoms of Shushkakshipaka, Schirmer test 1 positive less than 15 mm, Tear Film Breakup Time less than 15 seconds |
|
| ExclusionCriteria |
| Details |
Traumatic eye injury and Recent eye surgery, Ocular Allergy and Severe cases of dry eye disease with complications like perforated corneal ulcer, Uveitis, Glaucoma etc., Patients suffering from major systemic illness necessitating long term drug treatment |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of Shigru Patra Netrabindu and Goghrita Ashchyotan in the management of Shushkakshipaka w.s.r. to Dry Eye Disease |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study detail about Shushkakshipaka and Dry Eye Disease to study mode of action of Shigru Patra Netrabindu and Goghrita Ashchyotan |
15 days |
|
|
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)
|
17/09/2024 |
| 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="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
|
Now a days our lifestyle and work places are computerized. People do their work on computer up-to 6-8 hrs in offices. Due to pollution the environment has become dusty and dry, all these factors together cause eye irritation, burning, pricking sensation in eye which affect the tear production in eyes and causes Dry Eye Disease. Acharya Sushruta has described the symptoms of Shushkakshipaka in Sushruta Samhita Uttar Tantra as Kunitavartma, Daruna-rukshavartma, Aviladarshana, Gharshan, Toda, Bheda, Vishushkatwa, shoola. Shigru Patra Netrabindu and Goghrita Ashchyotan are selected. Netrabindu (Eye drops) is the simplest and most convenient method of topical application, especially for day time use. Application in the form of eye drops makes the drug available for immediate action. Shigru Patra has eminent properties like Vata Shamak and Chakshushya. Shigru is rich in Vitamin A and Vitamin A deficiency is also a cause of Dry Eye Disease. So it can be useful in Shushkakshipaka. Ashchyotan is an ancient method of preparation and said to be Pradhan Kriyakalp in Netrarogas. Goghrita is Vata Pittaghna as well as Chakshushya, Balya, Snehan as well as Ayushya. It has the quality of Snigdhata. It is smooth, lubricating and nurturing. |