CTRI

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CTRI Number

CTRI/2025/04/086031 [Registered on: 30/04/2025] Trial Registered Prospectively

Last Modified On:

29/04/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Ayurvedic management of Dry eye syndrome

Scientific Title of Study

An open labeled randomised comparative clinical study to evaluate the efficacy of Durva Ghrita eye drops and Rajanidaru eye drops combined with Triphaladi compound orally in Shushkakshipaka (Dry eye syndrome) and in-silico study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Vaidehi Dutt
Designation	MS Scholar
Affiliation	All India Institute of Ayurveda
Address	Room no. 505 Department of shalakya tantra 5th floor Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India
Phone	07982047917
Fax
Email	vaidehidutt365@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Manjusha Rajagopala
Designation	Head of department
Affiliation	All India institute of Ayurveda
Address	Room no. 512 Department of shalakya tantra 5th floor Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India
Phone	9560788850
Fax
Email	hod-shalakya@aiia.gov.in

Details of Contact Person
Public Query

Name	Dr Manjusha Rajagopala
Designation	Head of department
Affiliation	All India institute of Ayurveda
Address	Room no. 512 Department of shalakya tantra 5th floor Academic block All India Institute of Ayurveda Gautampuri Sarita Vihar New Delhi South DELHI 110076 India
Phone	9560788850
Fax
Email	hod-shalakya@aiia.gov.in

Source of Monetary or Material Support

All India Institute of Ayurveda Gautam Puri Sarita Vihar New Delhi 110076

Primary Sponsor

Name	All India Institute of Ayurveda New Delh
Address	All India Institute of Ayurveda Guatam Puri Sarita vihar New Delhi 110076
Type of Sponsor	Government medical college

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr vaidehi dutt	All India institute of Ayurveda , new delhi	room no 509 department of shalakya tantra 5th floor academic block all india institute of ayurveda Gautam Puri sarita vihar new delhi 110076 South DELHI	07982047917 vaidehidutt365@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committe All India Institute of Ayurveda	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:H041\|\|Other disorders of lacrimal gland. Ayurveda Condition: SUSHKAKSHIPAKAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Triphaladi compound, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -Unequal quantity of Ghee and Madhu ), Additional Information: -
2	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Durva ghrita, Reference: NA, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: -
3	Comparator Arm	Drug	Other than Classical		(1) Medicine Name: Triphaladi compound, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Weeks, anupAna/sahapAna: Yes(details: -unequal quantity of madhu and ghrita), Additional Information: -
4	Comparator Arm	Drug	Classical		(1) Medicine Name: Rajnidaru eyedrops, Reference: shushrut samhita, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 1(drops), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 6 Weeks, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	30.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1. Patients between the ages of 30 to 70 years regardless of sex. 2. The patient is capable and willing to take part in the research. 3. Individuals who exhibit the text described lakshana of Shushkakshipaka and signs and symptoms of dry eye illness.

ExclusionCriteria

Details

1. Severe cases of dry eye disease accompanied by uveitis, glaucoma and corneal ulcers, among other consequences.
2. Allergies and inflammations, such as giant papillary conjunctivitis, vernal keratoconjunctivitis and acute conjunctivitis.
3. Patients suffering from major systemic illness necessitating long term treatment ex. Psycho epileptic drug users etc.
4. History of hypersensitivity of the trial drug or any of its ingredients.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

An Open list of random numbers

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
Reduction in the clinical features i.e. foreign body sensation, dryness in the eyes, increase in Schirmer’s test result and Tear Break Up Time (BUT)	Evaluation of the patient during the treatment on 0th, 30th and 45th day

Secondary Outcome

Outcome	TimePoints
Overall improvement in the rest other symptoms & quality of life related to ocular health will be assessed according to OSDI Chart.	Evaluation of the patient during the treatment on 0th, 30th and 45th day

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 1

Date of First Enrollment (India)

15/05/2025

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="0"
Months="1"
Days="12"

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 study is an open label double arm randomised clinical trial comparing the efficacy of Durva ghrita eye drops(1 drop in each eye QID or as per requirement) and Rajanidaaru eye drops(1 drop in each eye QID or as per requirement) combined with Triphaladi compound(6 gm bd) orally for 42 days in patients of shuskakshipaaka (Dry eye syndrome) along with In-silico study .The trial will be conducted in All India institute of Ayurveda New Delhi.The primary outcome measures will be reduction in th clinical features i.e, foreign body sensation,dryness in the eyes,increase in schirmer test results and tear break-up time and the secondary outcomes will be overall improvement in rest of other symptoms and quality of life related to ocular health.