| CTRI Number |
CTRI/2024/08/072268 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| 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 clinical trial to study the effect of Triphala churna with Madhu in Timir with special reference to Simple Myopia |
|
Scientific Title of Study
|
A randomized controlled clinical trial to study the effect of triphala churna with madhu in timir 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 Ashwini Raosaheb Borude |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalakyatantra, SMBT Ayurved College and Hospital
Dhamangaon, Nashik
422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7447395700 |
| Fax |
|
| Email |
ashwini64borude@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kajal Tushar Firake |
| Designation |
Associate Professor |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalakyatantra, SMBT Ayurved College and Hospital
Dhamangaon, Nashik
422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
9850447661 |
| Fax |
|
| Email |
petalsayu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Raosaheb Borude |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital |
| Address |
Department of Shalakyatantra, SMBT Ayurved College and Hospital
Dhamangaon, Nashik
422403
Nashik
MAHARASHTRA
422403
India |
| Phone |
7447395700 |
| Fax |
|
| Email |
ashwini64borude@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
|
|
|
Primary Sponsor
|
| Name |
Dr Ashwini Raosaheb Borude |
| Address |
Department of Shalakyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra 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 Ashwini Raosaheb Borude |
SMBT Ayurved College and Hospital |
OPD No 8, Department of Shalakyatantra SMBT Ayurved College and Hospital Nandi hills Dhamangaon Igatpuri Nashik 422403 Maharashtra India
Nashik
MAHARASHTRA |
7447395700
ashwini64borude@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: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Aamlakyadi churna, Reference: Sushrut Samhita Sutrasthan (chapter no.38 , Shlok no.60,61), Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Churna, Reference: Chakradatta samhita (chapter no.59 , Shlok no. 94), Route: Oral, Dosage Form: Churna/ Powder, Dose: 1.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group between 18-30 years with the clinical symptoms of prathama patalgata timira (simple myopia)
2. Patients having -0.25 D to -3.00 D Spherical power with normal Fundoscopic findings |
|
| ExclusionCriteria |
| Details |
Congenital myopia, Pathological myopia, Acquired or Secondary type of myopia that occurs due to some factors or diseases i.e. post traumatic, drug induced etc.
Patients who have myopia assosiated with other refractive errors such as Astigmatism.
Patients who are known case of hypertension,diabetes mellitus.
Patients who have active infectious diseases ie viral, fungal, bacterial conjunctivitis, trachoma, blephritis,
Patients below 18 years and above 30 years
Patient who have refractive index more than -3 D spherical |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in signs and symptoms of timir after taking Triphala churna with madhu orally |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| where the trial group stands in comparison with control group |
18 months |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
15/08/2024 |
| 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 Yet Recruiting |
| 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
|
PURPOSE OF STUDY- Due to significance of myopia as a global health concern, In VISION-2020 which is the foremost large scale program run by WHO has one of its objective to control and treat uncorrected refractive errors.Myopia even of mild degree shuts the door of military, navy or pilot schools, for thousands of young people who dream of such professions.Myopia progression is irreversible and there is no cure. In modern science the treatment for myopia is use of eye glasses, contact lens and refractive surgeries like Laser assisted in-situ keratomileusis (LASIK), Laser assisted sub epithelial keratectomy (LASEK).Methods of correction of Myopia is not without complication including corneal infection due to contact lens wearing and corneal scaring and persistent corneal haze from refractive surgery.Refractive surgeries for treatment of myopia are both expensive and unsuitable for eyes of certain patients due to complication.Hence the ayurvedic science can be explored to serve a better alternative to manage this condition.In Ayurveda the use of local and systemic drugs is recommended in management of Timir.So there is a possibility to evolve a new remedy from Indian Medicinal Pharmacopeia particularly for Timira with special reference to Simple Myopia. AIM- To study the effect of Triphala churna with madhu in Timira with special reference to Simple Myopia. OBJECTIVES- 1.To study the improvement in symptoms of Timir with special reference to Simple Myopia.2.To study the changes in refractive powers after using Triphala churna with madhu for 30 days in Timir with special reference to Simple Myopia on the basis of subjective and objective criteria. HYPOTHESIS- NULL HYPOTHESIS: Triphala churna is not effective in Timir with special reference to Simple Myopia. ALTERNATIVE HYPOTHESIS: Triphala churna is effective in Timir with special reference to Simple Myopia. PROCEDURE- Approval from Institutional Ethical Committee (IEC) has been taken before commencement of trial.All patients diagnosed with Simple Myopia from assessment will be approached with the study proposal.Total 90 patients with Simple Myopia will be included after proper assessment and screening according to Inclusion and Exclusion Criteria.Those fulfilling the Inclusion criteria will be explained in details about the study in their most communicable language.Written informed consent in their preferred language will be obtained from the patients agreeing to participate.The patients will be randomly divided into two groups.In Group A Trial drug ie Triphala churna will be given and in Group B Control drug ie Amlakyadi churna will be given.Trial and Control drugs will be purchased from GMP Certified Pharmacy.Both drugs will be administrated orally for 30 days.Observations will be done on day 0,day 14,day 30 and day 45.Result of the study will be drawn on the basis of criteria of assessment and statistical analysis.Discussion will be done on the basis of observations and results obtained during treatment.Summary will be drawn and whole thesis work will be summarized. Conclusion will be drawn on the basis of statistical analysis and will be unbiased. |