| CTRI Number |
CTRI/2023/05/053219 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to see the effect of some Ayurvedic formulation in the treatment of near sightedness. |
|
Scientific Title of Study
|
Single arm clinical trial to evaluate the efficacy of oral administration of Chitrakadi Kwatha in the management of Prathama-Dwitiya Patalagata Timira with reference to myopia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SHIVRAJ SHRIRAM VANSURE |
| Designation |
MS SCHOLAR SHALAKYATANTRA (AYURVEDA) |
| Affiliation |
PUNE DEPARMENT OF SHALAKYATANTRA, MAMS SUMATIBHAI SHAH AYURVED COLLEGE, HADAPSAR. |
| Address |
OPD NO.09, DEPARTMENT OF SHALAKYATANTRA, SANE GURUJI AROGYAKENDRA, MALWADI ROAD, HADAPSAR, PUNE.
Pune
MAHARASHTRA
411028
India |
| Phone |
7304902999 |
| Fax |
|
| Email |
shivrajvansure20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PROF DR MRS NILAKSHI PRADHAN |
| Designation |
HOD SHALAKYATANTRA |
| Affiliation |
PUNE DEPARMENT OF SHALAKYATANTRA, MAMS SUMATIBHAI SHAH AYURVED COLLEGE, HADAPSAR. |
| Address |
OPD NO.09, DEPARTMENT OF SHALAKYATANTRA, SANE GURUJI AROGYAKENDRA, MALWADI ROAD, HADAPSAR, PUNE.
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF DR MRS NILAKSHI PRADHAN |
| Designation |
HOD SHALAKYATANTRA |
| Affiliation |
PUNE DEPARMENT OF SHALAKYATANTRA, MAMS SUMATIBHAI SHAH AYURVED COLLEGE, HADAPSAR. |
| Address |
OPD NO.09, DEPARTMENT OF SHALAKYATANTRA, SANE GURUJI AROGYAKENDRA, MALWADI ROAD, HADAPSAR, PUNE.
Pune
MAHARASHTRA
411028
India |
| Phone |
9423580963 |
| Fax |
|
| Email |
drnspradhan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF SHALAKYATANTRA, SANE GURUJI AROGYA KENDRA, MALWADI ROAD, HADAPSAR, PUNE. |
|
|
Primary Sponsor
|
| Name |
SANE GURUJI AROGYA KENDRA |
| Address |
SANE GURUJI AROGYAKENDRA, MALWADI, HADAPSAR, PUNE. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 SHIVRAJ SHRIRAM VANSURE |
SANE GURUJI AROGYA KENDRA, MALWADI ROAD, HADAPSAR. |
OPD NO 9, DEPARTMENT OF SHALAKYATANTRA, SANE GURUJI AROGYAKENDRA, MALWADI ROAD, HADAPSAR, PUNE.
Pune
MAHARASHTRA |
7304902999
shivrajvansure20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
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 | Drug | Classical | | (1) Medicine Name: Chitrakadi Kwatha, Reference: Vangasen Samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient Enrolled with symptoms of Prathama-Dwitiya Patalagata Timira i.e.
Avakatmekshateroopam (visual hallucination), Vyaktamapyanimitta (transient
nature of blurriness), Dooramnekshate (difficulty of distant vision) in Shalakya OPD.
2) Age-18 to 40 years.
3) Patient who have <-3D refractive index in the eyes.
4) Patient of either gender.
5) Patient having visual acuity of 6/12, 6/18, 6/24, 6/36, 6/60, or less than 6/60 in the
eyes.
6) Patient who ready to give consent. |
|
| ExclusionCriteria |
| Details |
1) Patient who have symptoms of Tritiya and Chaturtha Patalagata Timira will be
excluded.
2) Congenital type of myopia, pathological type of myopia, acquired or secondary type of
myopia that occurs due to some factors or diseases i.e. post traumatic, drug induced,
post keratitis. etc. will be excluded.
3) Myopia associated with other ocular diseases like cataract, glaucoma, etc.
4) Patient who have myopia associated with other refractive errors such as astigmatism,
presbyopia.
5) Patient who have known case of hypertension, diabetes mellitus, Rheumatic arthritis
or any other arthritic conditions, rheumatic heart disease, thyroid disorder, asthma,
Koch’s, HIV will be excluded.
6) Patient who have active infectious diseases i.e. viral, fungal, bacterial conjunctivitis,
trachoma, blepharitis.
7) Patient below 18 years and above 40 years will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptoms like Avakatmekshateroopam (visual hallucination), Vyaktamapyanimitta (transient nature of bluriness), Dooramnekshate (difficulty of distant vision) will be decreased and relief from myopia. |
Follow of will be taken on 7th, 15th day and symptoms will be noted of before and after treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in visual acuity of patient, decrease in severity and duration of symptoms |
18months. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
15/06/2023 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The visual disturbance is represented as one of the complex problem in the field of
ophthalmology. Myopia is
refractive error in which parallel rays of light from an infinity enters the eye and is focused
in front of retina, when accommodation is at rest. The progress of the disease myopia causes gradual loss of vision and
sometime it causes severe visual impairment.
In modern science the treatment for myopia is use of eyeglasses, contact lens, laser assisted in situ keratomileusis(LASIK), laser-assisted sub epithelial keratectomy(LASEK),
refractive keratometry. In Ayurveda, when the vitiated Doshas invades Patala, the patient complains about
the symptoms of disease i.e. difficulty to see distant object or blurred vision. etc. and if
untreated it shifts to next Patala. But according to Ayurvedic Samhita, Prathama-Dwitiya
Patalagata Timira is Aushdha Sadhya Vyadhi. modern techniques i.e. refractive surgeries for treatment for myopia are costly hence the Ayurvedic science is better alternative for
this condition.
The oral administration of Chitrakadi Kwatha is an easy and feasible procedure. It is
also affordable to patient. It prevents pathology of Timira. Dravyas includes in yoga
includes are Chitrakmula, Triphala, Patol, Yava and Ghrita. Oral administration of
Chitrakadi Kwatha which is said by Acharya Vangasen is selected for study. Purpose of study is found out solution for Prathama Dwitiya Patalagata Timira |