| CTRI Number |
CTRI/2025/03/082984 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
30/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of rasna dasamoola ghritha internally and eyelid massage with ksheerabala taila seven avarti in myopic astigmatism |
|
Scientific Title of Study
|
Combined effect of rasna dasamoola ghritha internally and netra abhyangam with ksheerabala taila (7 avarti) in myopic astigmatism in the age group of 5-16 years |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anagha T |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College, Kannur |
| Address |
Department of Shalakya tantra
Government Ayurveda College
Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
9400196116 |
| Fax |
|
| Email |
idranagha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambili K |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurveda College, Kannur |
| Address |
Department of Shalakya tantra Government Ayurveda College
Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
9446028794 |
| Fax |
|
| Email |
amlikavinal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anagha T |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurveda College, Kannur |
| Address |
Department of Shalakya tantra Government Ayurveda College
Pariyaram
Kannur
Kannur
KERALA
670503
India |
| Phone |
9400196116 |
| Fax |
|
| Email |
idranagha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda College,
Pariyaram,
Kannur
Kerala
India
670503 |
|
|
Primary Sponsor
|
| Name |
Anagha T |
| Address |
Government Ayurveda College, Pariyaram
Kannur
Kerala
India
670503 |
| 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 |
| Anagha T |
Government Ayurveda College, Kannur |
Department of Shalakya tantra
Government Ayurveda College
Pariyaram
Kannur
Kannur
KERALA |
9400196116
idranagha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Ayurveda College Kannur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H522||Astigmatism. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasna dasamoola ghritha, Reference: Ashtanga hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 15(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Participant will be advised to take 5 to 15ml Rasna dasamoola ghritha internally at night 30
minutes after food for a period of 30 days.
Dose fixation will be done according to age using Young’s Formula. | | 2 | Intervention Arm | Procedure | - | aBya~ggaH, अभ्यंग | (Procedure Reference: Ashtanga Hridaya, Procedure details: The procedure will be demonstrated to the participant on the first day & will be instructed
to do the same for rest of the days either by oneself or by parents.
3 drops of Ksheerabala taila 7 avarti taken in a gokarna will be made lukewarm by placing
it over hot water.
Participant will be seated in a comfortable position.
Ksheerabala taila 7 avarti will be taken in fingertips and massage will be done around
closed eyes separately in a circular manner for 2 minutes.
Excess oil will be wiped off with cotton.
Participant will be advised to take rest for 5min.
)
(1) Medicine Name: Ksheerabala taila 7 avarti, Reference: Ashtanga Hridaya, Route: Topical, Dosage Form: Taila, Dose: 3(drops), Frequency: bd, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Participants with best corrected visual acuity greater than or equal to 0.18 in LogMar visual acuity chart.
Participants who are willing to give an informed verbal or written assent and parents
consent. |
|
| ExclusionCriteria |
| Details |
Participants with previous ocular surgery or trauma.
Participants with any other ocular pathologies.
Participants with mandagni. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement of unaided and aided visual acuity in patients with
myopic astigmatism using LogMar visual acuity chart. |
Visual acuity assessment will be done on 0th, 15th
, 31st, 46th and 61st day of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement dioptric power of eyes in patients with myopic
astigmatism using retinoscope, autorefractometer and subjective method of
refraction.
|
Refraction done on 0th, 31st and 61st day. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/04/2025 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Astigmatism is a common refractive error which causes blurry vision. Myopic astigmatism comes under refractive type of regular astigmatism. Asthenopia, defective vision and distortion of objects are the common symptoms of astigmatism. Conventional treatment methods include wearing corrective lenses or refractive surgery. Refractive errors are included under Timira roga in Ayurveda classics. The symptoms of myopic astigmatism bear resemblance to those of Prathama patala gata vatika timira. Acharya Vagbhata mentioned Snehapana initially while explaining Timira chikitsa. In the outpatient treatment, use of Rasna dasamoola ghritha internally and netra abhyanga with Ksheerabala taila (7 avarti) is found to yield positive results in patients with myopic astigmatism. Rasna dasamoola ghritha is a formulation containing drugs mainly of vatahara and brimhana properties. Ksheerabala taila is having rasayana and indriya prasadana action. Therefore, the study was planned to assess the combined action of Rasnadasamoola ghritha internally and netra abhyangam with Ksheerabala taila (7 avarti) in myopic astigmatism. The study was designed as a pre and post interventional study with a sample size of 34 participants in the age group of 5 to 16 years irrespective of gender from the outpatient department of Shalakyatantra, Govt. Ayurveda College Hospital, Kannur. The intervention was given for 30 days. Changes in visual acuity from baseline was assessed on 15th, 31st, 46th and 61st day and changes in refraction on 31st day and 61st day.Unaided visual acuity in both eyes showed statistically significant improvement following treatment and remained stable during follow-up. (p<0.001). Significant improvement in refractive status was observed in retinoscopy and subjective refraction. No statistically significant improvement was seen in autorefractometry. |