| CTRI Number |
CTRI/2025/06/089411 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Darvyadi Aschyotana(Eyedrop) and Shunthyadi Aschyotana(Eye drop) in the management of Dry eye disease. |
|
Scientific Title of Study
|
Efficacy of Darvyadi Aschyotana(Eye drop-Anubhuta)and Shunthyadi Aschyotana(Eye drop) in the management of Shushkaakshipaka(Dry eye disease)-an open labelled randomized comparative clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gargi Mohan P |
| Designation |
Ph.D. scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Department of Shalakyatantra
Institute of Teaching and Research in Ayurveda,Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9496730945 |
| Fax |
|
| Email |
gargimohanpoloor@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D K Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th Floor
Department of Shalakyatantra
I.T.R.A.,Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379713 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr D K Pawar |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
4th Floor
Department of Shalakyatantra
I.T.R.A.,Jamnagar
Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7737379713 |
| Fax |
|
| Email |
drpawar29@itra.edu.in |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Near b division Police station, Jamnagar, Gujarat, India 361008 |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda, Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda, Near b division Police station, Jamnagar, Gujarat, India 361008 |
| 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 Gargi Mohan P |
Institute of Teaching and Research in Ayurveda, Jamnagar |
Opd no:2, Shalakya Tantra department, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat 361008
Jamnagar
GUJARAT |
9496730945
gargimohanpoloor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Institute of Teaching and Research in Ayurveda |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H048||Other disorders of lacrimal system. Ayurveda Condition: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahatriphaladi Ghrita , Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - | | 2 | Intervention Arm | Procedure | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: Sushruta Samhita, Procedure details: Instillation of 2 drops of medicine at the inner canthus of eyes at a height of approximately 3-4 cm.)
(1) Medicine Name: Darvyadi Ghrita, Reference: Anubhuta, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: tds, Duration: 1 Months | | 3 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hridaya , Procedure details: Instillation of specific dose of medicine into both the nostrils after Snehana and Swedana)
(1) Medicine Name: Anutaila, Reference: Ashtanga Hridaya, Route: Nasal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 14 Days | | 4 | Comparator Arm | Procedure | - | AScyotanam, आश्च्योतनम् | (Procedure Reference: Sushruta Samhita, Procedure details: Instillation of 2 drops of medicines at inner canthus of eyes at a height of approximately 3-4 cm.)
(1) Medicine Name: Shunthyadi Ghrita, Reference: Anubhuta, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: tds, Duration: 1 Months | | 5 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Mahatriphaladi Ghrita , Reference: Chakradatta, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Koshnajala), Additional Information: - | | 6 | Comparator Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtanga Hridaya , Procedure details: Instillation of specific dose of medicine into both the nostrils after Snehana and Swedana)
(1) Medicine Name: Anutaila, Reference: Ashtanga Hridaya, Route: Nasal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 14 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Irrespective of gender, caste, religion and socioeconomic status.
2. Patients between age group of 18 and 60 years.
3. Patients presenting with minimum 3 symptoms and at least one positive test of Dry Eye Disease. |
|
| ExclusionCriteria |
| Details |
1.Dry Eye due to any local cause e.g., Chemical Burn, Xerosis.
2.Dry Eye due to systemic disease like Sjogren’s syndrome.
3.Patients on Steroids, anticholinergic drugs, Oral Contraceptive Pills, Estrogen Replacement Therapy, or any other medication such as Antispasmodic drugs may adversely affect the outcome of the study.
4.Persistent contact lens users.
5.Patients having chronic debilitating diseases like HIV, Tuberculosis, Malignancy, uncontrolled Diabetes Mellitus and uncontrolled Hypertension, Pregnant ladies and lactating mothers.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in signs and symptoms of Shushkaakshipaka (Dry eye disease) during the treatment period of 1 month on 15th and 30th day. |
On 0th day ( before treatment), 15th and 30th day (after treatment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of recurrence of signs and symptoms of Shushkaakshipaka(Dry eye disease) |
During followup period on 15th and 30th day |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/07/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gargimohanpoloor@gmail.com].
- For how long will this data be available start date provided 15-07-2025 and end date provided 15-10-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Dry eye is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyper osmolality, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles. Hyper osmolality causes release of chemical substances like inflammatory mediators and proteases which causes histological changes like loss of goblet cells and epithelial cells. The condition gradually progresses to punctuate epitheliopathy and ultimately ocular surface damage. In Ayurveda, On the basis of signs and symptoms it can be correlated with Shushkaakshipaka. Shushkaakshipaka mentioned as Sarvagata Netraroga among all the 76 Netrarogas by Acharya Sushruta and mentioned it as Vata predominant Vyadhi. The mainstay of management of Dry Eye Disease in contemporary medicine is by instillation of artificial tear supplements, preservation of natural tears & excess mucous may be treated by acetyl cystine & in severe cases some ocular surgeries. The tear lubricants mentioned are a failure in reproducing the tears because the natural tears are a complex mixture of lipids, mucin and water. Mainly this has a local effect only and, it can’t break the root cause of pathology which often results in recurrence.Also, the main problem is the cost of these medicines. These are prescribed as lifelong therapy and many of the patients will not be in a position to afford these expensive drops. This has paved way for other medical systems, like Ayurveda, to propose experiments and offer alternative treatments for the Dry eye syndrome. Two Groups A and B will be allocated with 50 patients in each group using Computer Generated Random Sampling Method. Group A will be provided with Darvyadi Aschyotana 2 drops 4 times in a day and Group B with Shunthyadi Aschyotana with the same dosage and time interval for 30 days. Both groups will provide with Mahatriphaladi Ghrita Pana 15ml OD in empty stomach for 30 days and with Anutaila Nasya with 5ml in each nostrils at evening for 14 days.subjective and objective assessment will be done on 15th and 30th day.After completion of the treatment, the patients will be asked for follow up for 1 month at the interval of 15 days.
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