| CTRI Number |
CTRI/2025/09/094655 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study on patients with nearsightedness (Pratham Patalgata Timir) to compare the effect of two Ayurvedic eye therapies (Jeevantyadi Ghrit Tarpan and Mahatriphaladi Ghrit Tarpan) along with an oral Ayurvedic medicine (Saptamrit Lauh). |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Jeevantyadi Ghrit and Mahatriphaladi Ghrit Tarpan with Saptamrit Lauh Orally in Pratham Patalgata Timir |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shan Chandel |
| Designation |
PG Scholar Shalakya |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar |
| Address |
OPD-1 Shalakya Tantra
Patanjali Ayurveda Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1,Haridwar,Uttarakhand , India
249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8219897280 |
| Fax |
|
| Email |
shan.chandel1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dayashankar Singh |
| Designation |
Head of Department ,Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar |
| Address |
OPD-1 Shalakya Tantra
Patanjali Ayurveda Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1,Haridwar,Uttarakhand, India
249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8194028515 |
| Fax |
|
| Email |
dayaayush@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shan Chandel |
| Designation |
PG Scholar Shalakya |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar |
| Address |
OPD-1 Shalakya Tantra
Patanjali Ayurveda Hospital
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase 1,Haridwar,Uttarakhand, India
249405
haridwar
UTTARANCHAL
249405
India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8219897280 |
| Fax |
|
| Email |
shan.chandel1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar, Uttrakhand, India 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusansthan Sansthan, Haridwar, Uttarakhand, India 249405 |
| 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 Shan Chandel |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Haridwar |
OPD-1, Department of Shalakya- Tantra, Patanjali Ayurveda Hospital, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan ,Phase 1,Haridwar, Uttarakhand ,India
Pin code -249405
Hardwar
UTTARANCHAL |
8219897280
shan.chandel1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee,Patanjali Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H521||Myopia. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: As.hr.Su24/1-2, Procedure details: In this procedure the eye is filled upon with medicated ghee or oil for a certain period of time .)
(1) Medicine Name: Jeevantyadi Ghrit , Reference: As.Hr.Ut.13/2-3, Route: Ocular, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: As.Hr.Su.24/1-2, Procedure details: In this procedure the eyes are filled upon with medicated ghee or oil for a certain period.)
(1) Medicine Name: Mahatriphaladi Ghrit, Reference: Bhaisajya Ratnavali64/225-229, Route: Ocular, Dosage Form: Ghrita, Dose: 30(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with symptoms of Simple myopia.
2. Patient between the age group 8 to 40 years of either sex.
3. Patients who are fit for Tarpan karma.
4. Patient having lakshanas of Pratham Patalgata Timir.
5. Patients with refractive error less than 6D. |
|
| ExclusionCriteria |
| Details |
1.Patient less than 8 year of age and above 40 year of age.
2.Patient suffering from any other systemic disease and receiving medicine for the
same.
3.Patients who are unfit for Tarpan karma.
4.Patients with refractive error more than 6D. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of Subjective parameter
1 Avyaktani sa rupani
2 Strain in eyes
3 Headache
|
Baseline (before treatment); End of treatment (4 weeks, primary time point) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment will be done on the basis of Objective parameters
Objective parameters
1 Visual acuity
2 Refractive assessment |
Time: Baseline (before treatment); End of treatment (4 weeks). |
|
|
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 |
|
Date of First Enrollment (India)
|
23/09/2025 |
| 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
|
In this trial, patients diagnosed with Pratham Patalgata Timir will be selected and randomly divided into two groups, with 30 patients in each group. Group A Patients will receive the Ayurvedic procedure of Tarpan with Jeevantyadi Ghrit, along with oral administration of Saptamrit Lauh. Group B Patients will receive the Ayurvedic procedure of Tarpan with Mahatriphaladi Ghrit, along with oral administration of Saptamrit Lauh. Assessment will be carried out on the basis of both subjective and objective parameters. One follow-up will be conducted 30 days after the completion of treatment. |