| CTRI Number |
CTRI/2026/01/102306 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
22/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on combined effect of Shatavaryadi Churna along with Phalatrikadi Ghrita Tarpana in treating Simple Myopia. |
|
Scientific Title of Study
|
A RANDOMISED CONTROLLED CLINICAL TRIAL TO STUDY THE ADJUVANT
EFFECT OF SHATAVARYADI CHURNA ALONG WITH PHALATRIKADI GHRITA
TARPANA IN PRATHAM PATALGATA TIMIRA WITH SPECIAL REFERENCE TO
SIMPLE MYOPIA. |
| 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 Shreya Babaso Kamble |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403 |
| Address |
OPD no 16,Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7038816195 |
| Fax |
|
| Email |
shreyakamble900@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal Tushar Firake |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403 |
| Address |
OPD no 16,Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9850447661 |
| Fax |
|
| Email |
petalsayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreya Babaso Kamble |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403 |
| Address |
OPD no 16,Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7038816195 |
| Fax |
|
| Email |
shreyakamble900@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Babaso Kamble |
| Address |
OPD No 16,Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri,Nashik 422403 Nashik Maharashtra 422403 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 Shreya Babaso Kamble |
SMBT Ayurved College and hospital. |
OPD no 16, Department of Shalakyatantra , SMBT Ayurved College and hospital , Dhamangaon, Igatpuri , Nashik 422403
Nashik
MAHARASHTRA |
7038816195
shreyakamble900@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: PRATHAMA-PATALAGATADOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: सु.उ.18/5-11, Procedure details: Phalatrikadi Ghrita Tarpana will be done- 2 cycles of tarpana ( each cycle of seven days) with a gap of seven days in between them. Tarpana matra- 200-800.)
(1) Medicine Name: Phalatrikadi Ghrita , Reference: चक्रदत्त नेत्रचिकित्सा/ १७९, Route: Ocular, Dosage Form: Ghrita, Dose: 65(g), Frequency: od, Duration: 14 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi Churna, Reference: यो.र.नेत्रचिकीत्सा 1-3, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: 2 cycles of Phalatrikadi Ghrita Tarpana with a gap of seven days in between them , with oral administration of 3 gm of Shatavaryadi Churna ,twice a day for 21 days. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient with symptoms of Pratham Patalagata Timira like Indistinct
distant vision, Eye strain, headache.
2) Patient aged 18 to 30 yrs
3)Patient who have less than -3D refractive index in the eyes with normal
ophthalmic findings. |
|
| ExclusionCriteria |
| Details |
1) Patient who have symptoms of Dwitiya,Tritiya and Chaturtha
Patalagata Timira will be Excluded.
2) Congenital myopia, pathological myopia and acquired or secondary
myopia resulting from factors or conditions such as trauma, drug
use or post-keratitis will be excluded.
3) Patient who have myopia associated with other refractive errors
such as Astigmatism or other ocular diseases like cataract,
glaucoma, retinal diseases etc. will be excluded.
4) Patients with a known history of DM, hypertension, rheumatic
heart disease, thyroid disorders, asthma, tuberculosis (Koch’s), HIV
or with active infectious diseases like viral, fungal, or bacterial
conjunctivitis, trachoma or blepharitis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the adjuvant effect of Shatavaryadi Churna along with Phalatrikadi ghrita Tarpana in signs and symptoms of Pratham Patalgata Timira with the help of assessment criteria. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group in reduction of signs and symptoms of Pratham Patalgata Timira. |
18 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="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
|
This study is a randomised controlled clinical, parallel group,open label trial to study the effect of Shatavaryadi Churna along with Phalatrikadi ghrita Tarpana in Pratham Patalgata Timira with special reference to Simple Myopia.
Pratham Patalgata Timira is a disease mentioned in Ayurveda under Drishtigata Netraroga which is caused by vitiated Vata Pitta Dosha according to Ayurveda. It can be co related to Simple Myopia mentioned in modern texts. It is becoming more common due to factors like excess usage of digital devices, lifestyle changes,etc. Spectacles offer only temporary relief without addressing the root causes of Simple Myopia. As per Yogaratnakara, Shatavaryadi Churna is a simple oral treatment for Timira with Vata-Pitta shamaka and Chakshushya properties. Sushruta and Vagbhata describe Tarpana as the best therapy for Timira. Hence, Shatavaryadi Churna with Phalatrikadi Ghrita Tarpana may relieve symptoms and slow disease progression.
This is why the topic was selected for further study.
Patient having age group of 18 to 30 years irrespective of gender and occupation and having classical sign and symptoms of Pratham Patalgata Timira will be selected randomly for the present study. Method of assessment includes Subjective criteria and objective criteria as follows- Subjective criteria- 1)Indistinct distance vision 2)Eyestrain 3)Headache
Objective criteria- 1)Snellen’s chart for distance vision 2)Autorefractometer
Consent would be obtained from each patient prior to study. Computerised generated Sampling technique will be used.
The total sample size for study will be taken as 50. It will be divided into two groups as: Group A as the TRIAL group -Shatavaryadi Churna orally ,3gm, BD for 21 days along with 2 cycles of Phalatrikadi ghrita Tarpana with a gap of seven days in between them .
Group B as the CONTROL group- 2 cycles of Phalatrikadi ghrita Tarpana with a gap of seven days in between them .
Observation of each patient will be done on 0th,7th ,14th ,21st day and follow up on 28th day based on pre designed proforma and assessment criterias for both the groups.
The study would evaluate the impact of Shatavaryadi Churna and Phalatrikadi Ghrita Tarpana on the signs and symptoms of Pratham Patalgata Timira after 21 days of treatment.
Result of study will be drawn on the basis of assessment criteria and statistical analysis. Discussion will be done on the basis of observations and result obtained.Summary will be drawn and conclusion will be drawn on basis of statistical analysis and will be unbiased. |