| CTRI Number |
CTRI/2025/12/099130 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
12/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Manjishtadi Anjana For Shushkakshipak (Dry Eye Disease) |
|
Scientific Title of Study
|
An Open Randomised Controlled Clinical Trial Evaluating The Efficacy Of Manjishtadi Anjana in Shushkakshipak |
| 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 Sneha Raju Pujari |
| Designation |
MS Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Centre Ashta Sangali |
| Address |
Hon Shri Annasaheb Dange AyurvedMedical College And Research Centre Ashta Sangali
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangali Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
08767993473 |
| Fax |
|
| Email |
snehapujari1122@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayavant Vasant Kharat |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Centre Ashta Sangali |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Centre Ashta
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangali Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
09604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayavant Vasant Kharat |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Centre Ashta Sangali |
| Address |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Centre Ashta
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangali Maharashtra
Sangli
MAHARASHTRA
416301
India |
| Phone |
09604010037 |
| Fax |
|
| Email |
jayvantkharat55@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate And Research Centre Ashta Tal Walwa Dist Sangali Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Raju Pujari |
| Address |
OPD No 5 Shalakyatantra OPD Ground Floor Dhanvantari Hospital Ashta Tal Walwa Dist
Sangali Pin code 416301 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 |
| Dr Sneha Raju Pujari |
Hon Shri Annasaheb Dange Ayurved Medical College And Research Centre Ashta |
Department of Shalakyatantra OPD/IPD Sangali Maharashtra
Sangli
MAHARASHTRA |
08767993473
snehapujari1122@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee Of Hon Shri Annasaheb Dange Ayurved Medical College And Post Graduate And Research Centre Ashta Sangali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, (2) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: Dryey, (3) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: Shusk, (4) ICD-10 Condition:H578||Other specified disorders of eye and adnexa. Ayurveda Condition: SARVAGATAKSHIROGAH, (5) ICD-10 Condition: H579||Unspecified disorder of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Sharangdhar samhita khand 3, Procedure details: Vartma should be held firmly with left hand so that the patient connot blink eyelids.
Hold the shalaka in right hand and apply the anjana from kananika to apang sandhi in one time.
After applying of anjana the eyes should remain closed and patient should be askedto mildly rotate the eyeballs inside the lids.)
(1) Medicine Name: Manjishtadi Anjana, Reference: Ashtang sangraha uttartantra, Route: Ocular, Dosage Form: Churna/ Powder, Dose: 0.5(mg), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | anjanam | (Procedure Reference: Sharangdhar samhitakhand 3, Procedure details: Procedure details: Vartma should be held firmly with left hand so that the patient connot blink eyelids. Hold the shalaka in right hand & apply the anjana from kananika to apang sandhi in one time. After applying of anjana the eyes should remain closed & patient should be askedto mildly rotate the eyeballs inside the lids.))
(1) Medicine Name: Mahaoushadhi Anjana, Reference: Ashtanghridaya ,Choukhamba Sanskrit Sansthan Varanasi ,Uttarsthan 16/29, Route: Ocular, Dosage Form: Kalka/ Paste, Dose: 5.8(mg), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients suffering from symptoms of shuskakshipak (Netrashushkata, Daha ,Gharsha, Aavildarshanam, Krichronmeelanimeelana, etc.)
2.Patients of age group between 18-55yrs irrespective gender.
3.Patients having excessive outdoowork exposed to sunlight for more than 3hrs.
4.Patients having IT profession, those who have screen time more than 3 hrs.
5.Patients willing to take part in treatment.
|
|
| ExclusionCriteria |
| Details |
Patient having any congenital eye anomaly.Patient having occular disease or infection.Patient having history of immediate ocular surgery.Patient refuse to continue treatment. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Manjishtadi Anjana is effective in management of Shushkakshipak |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mahaoushadhi Anjana is effective in management of Shushkakshipak |
7 days |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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)
|
23/12/2025 |
| 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="6"
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
|
The dry eye is not a disease entity, but a symptom complex occurring as a sequelae to deficiency or abnormalities of the tear film
Shushkakshipak is caused due to affliction of vata ,pitta dosha having symptoms of netrashushkata, darunvartma, pak ,tod, bheda, updeh, aavildarshanm, krucchonmilana. According to modern science shushkakshipak is corelated with dry eye syndrome.it is condition that results from an insufficient production of tears or an excessive evaporation of tear film . Netra anjana is ayurvedic purification and reguvention treatment specially as a part of 7 kriyakalpa of panchkarma treatment. In this procedure ask the patient in lie down position.Clean the eyes with wet cotton then vartma is firmly held with left hand and apply anjana with right hand with help of anjana shalaka. Anjana is applied from kananika sandhi to apang sandhi. After applying anjana ask the patient to close eyes and mildly rotate the eyeballs inside the kids. Manjishtadi anjana includes manjishta, haritaki, bibhitaki, daruharidra and lohbhasm. All these conte ts are chakshushya., rejuventaing, varnya, drshtiparasadak, akshivishahara. |