| CTRI Number |
CTRI/2026/02/103243 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
This clinical trial will be performed to understand the efficacy of Yashtimadhu Siddha Taila Nasya with Carboxy Methylcellulose Eye Drop in Dry Eye Syndrome which includes the symptoms such as Irritation or Foreign body sensation in eyes, Dryness, Itching, Blurry vision, Excessive blinking etc. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study to Evaluate the efficacy of Yashtimadhu Siddha Taila nasya and Carboxy Methylcellulose (CMC) Eye Drop in Dry Eye Syndrome. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Avani Prabhakar Ganer |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Third floor Shalakyatantra department Sector No. 25 Pradhikaran Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
7389737773 |
| Fax |
|
| Email |
avaniganer1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Darunde |
| Designation |
Asst. Professor Shalakyatantra department |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Third floor Shalakyatantra department Sector No. 25 Pradhikaran Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
8983088238 |
| Fax |
|
| Email |
swd420@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Darunde |
| Designation |
Asst. Professor Shalakyatantra department |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Third floor Shalakyatantra department Sector No. 25 Pradhikaran Nigdi
Pune
MAHARASHTRA
411044
India |
| Phone |
8983088238 |
| Fax |
|
| Email |
swd420@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Sector No. 25 Pradhikaran Nigdi Pune
Maharashtra India 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Third Floor Shalakyatantra department Sector No. 25 Pradhikaran Nigdi Pune |
| Type of Sponsor |
Private medical college |
|
|
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 Avani Prabhakar Ganer |
Ayurved Rugnalaya and Snowbell Multispeciality Hospital |
Shalakyatantra OPD 122, Sector No. 27, Pradhikaran Nigdi, Pune 411044
Pune
MAHARASHTRA |
7389737773
avaniganer1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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: NETRAROGAH/AKSHIROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Ophthalmic drug administration | Drug - Carboxymethylcellulose 0.5% eye drops, Route of administration - topical, Dose - 1 drop in each eye 3 times a day, Duration of treatment - 15 days with follow up on 7th and 15th day. | | 2 | Intervention Arm | Procedure | - | nasyam/ nastam, नस्यम्/ नस्तम् | (Procedure Reference: Ashtang Hridayam, Procedure details: Starts with Facial oil massage (Snehan); then application of steam to face, forehead, ears and neck (Swedan). Instillation of lukewarm Yashtimadhusiddha taila in both the nostrils - 6 drops, alternately, with the help of dropper. Lie down in resting position for atleast 1.5 minutes. Follow up will be taken on 7th and 15th day.)
(1) Medicine Name: Yashtimadhusiddha tail Nasya, Reference: Vangasena Samhita, Nighantu Adarsh, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 6(drops), Frequency: od, Duration: 15 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients showing minimum 3 symptoms of dry eye syndrome – Irritation, Itching or Foreign body sensation in eyes, Feeling of dryness, Blurring of vision, Ocular fatigue, Excessive blinking. |
|
| ExclusionCriteria |
| Details |
Known case of any acute infective condition or congenital anomalies of the eyes, Severe dry eye with corneal involvement, Tumours of the eye, Steven-Johnson syndrome, Post intraocular surgery operated within 1 month, No allergic rhinopathy. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To identify the difference in between the treatment for the management of dry eye syndrome.
To compare the effectiveness of treatment over the period of time.
To compare the efficacy of yashtimadhusiddha taila nasyakarma with CMC 0.5% eye drop. |
15 days treatment with 2 follow ups on 7th and 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the efficacy of Carboxymethylcellulose 0.5% eye drop with yashtimadhusiddha taila.
To observe the adverse effect of drug, if any. |
15 days treatment with 2 follow ups on 7th and 15th 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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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
|
Dry eye syndrome is a multi-factorial disease of the ocular system. It results either from tear deficiency or excessive evaporation of the tear film which makes it unstable, causing ocular surface inflammation. In todays world, use of technology is increasing and leading to increased screen time which is affecting eyes very badly. Polluted air, dry air, heat, dust etc are favourable for the disease causing increased number of cases of dry eyes. At present there is no permanent cure for dry eye syndrome. Lubricating eye drops are used to reduce the symptoms but prolonged use may develop resistance. Nasya is prescribed line of treatment in many eye diseases. In this study, Yashtimadhusiddha tail nasya is taken for study to check if it is effective against carboxymethylcellulose 0.5% eye drops in dry eye syndrome. |