| CTRI Number |
CTRI/2024/10/074834 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to study the effects of two drugs, Marichanjana and Vachadi Kashaya, in Elderly patients with Early stage of
Cataract. |
|
Scientific Title of Study
|
A Clinical study on the effect of Marichanjana in comparison with Marichanjana along with Vachadi Kashaya internally in Kaphaja Kacha with special reference to Senile Immature Cataract. |
| 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 V ARCHANA |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Ayurveda Medical College, Bengaluru |
| Address |
Department of PG Studies in Shalakya Tantra,
Government Ayurveda Medical College,Dhanvantari road, Majestic, Bengaluru.
Bangalore
KARNATAKA
560009
India |
| Phone |
6380566057 |
| Fax |
|
| Email |
gaathygayathri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RATHI S |
| Designation |
PROFESSOR |
| Affiliation |
Government Ayurveda Medical College, Bengaluru |
| Address |
Department of PG Studies in Shalakya Tantra,
Government Ayurveda Medical College,Dhanvantari road, Majestic, Bengaluru.
Bangalore
KARNATAKA
560009
India |
| Phone |
8970779550 |
| Fax |
|
| Email |
drrathi.s@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V ARCHANA |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Ayurveda Medical College, Bengaluru |
| Address |
Department of PG Studies in Shalakya Tantra,
Government Ayurveda Medical College,Dhanvantari road, Majestic, Bengaluru.
Bangalore
KARNATAKA
560009
India |
| Phone |
6380566057 |
| Fax |
|
| Email |
gaathygayathri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr V ARCHANA,Government Ayurveda Medical College, Bengaluru. |
|
|
Primary Sponsor
|
| Name |
Dr V ARCHANA |
| Address |
OLD NO.23,NEW NO.9,MAIN ROAD, ANNAMALAI NAGAR,OPPOSITE TO BHARAT PETROL PUMP, 45 FEET ROAD, PUDUCHERRY-605013. |
| 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 V ARCHANA |
Sri Jayachamarajendra Ayurveda and Unani Hospital, Bengaluru |
Department of PG Studies in Shalakya Tantra, Shalakya Tantra (Eye) OPD, Room No.11, Government Ayurveda Medical College, Dhanvantari Road, Majestic, Bengaluru-560009
Bangalore
KARNATAKA |
6380566057
gaathygayathri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,Government Ayurveda Medical College, Bengaluru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H258||Other age-related cataract. Ayurveda Condition: KACAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Marichanjana, Reference: Basavarajiya, Netra roga nidana lakshana chikitsadaya, Sloka 151., Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 50(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Varti is rubbed with water and made into a paste form, and then applied as anjana. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Marichanjana, Reference: Basavarajiya, Netra roga nidana lakshana chikitsadaya, Sloka 151., Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 50(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Varti is rubbed with water and made into a paste form, and then applied as anjana.(2) Medicine Name: Vachadi Kashaya, Reference: Chikitsa Sara Sangraha, Netra roga adhikara, Sloka 458 and 459., Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 48(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age group: 50-70years.
2) Patients of either gender .
3) Patients with classical features of Kaphaja Kacha (Immature cataract) with signs and symptoms like:
a)Blurriness of vision
b)Glare
c)Floaters
d)Greyish white :Lens colour
e)Iris shadow
f)Distant direct ophthalmoscopy with dilated pupil: Multiple dark areas against red fundal glow
g)Slit lamp examination: Areas of normal with cataractous cortex.
4) Visual acuity of 6/9 to CF+ |
|
| ExclusionCriteria |
| Details |
1) Senile Mature and Hypermature cataract, Nuclear cataract.
2) Congenital, developmental, traumatic, complicated and metabolic cataract, post surgical cataract etc.
3) Immature cataract associated with systemic diseases (except Controlled Diabetes- HbA1c not more than 7%, Controlled Hypertension).
4) Any other ocular pathology that can cause diminution of vision.
5) Patients contra-indicated for Anjana karma. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
• Slit lamp examination -Lens Opacity Classification System III (LOCS III) grading
• Visual Acuity grading
• Blurriness of vision grading |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Glare grading
• Floaters grading |
60 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
16/10/2024 |
| 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="0"
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
|
Vision- the ability to see, perceive, interpret and enjoy the surroundings, is one of the greatest assets a human is blessed with. Unfortunately, 94 million people are blind or visually impaired globally and cataract is the most common cause of blindness worldwide. However, most cases of blindness are avoidable.The annual incidence of cataract blindness in India is about 3.8 million. Senile cataract is the most important variant of avoidable blindness.
Cataract refers to development of any opacity in the lens or its capsule. There is no direct mentioning of Senile immature cataract in Ayurveda. However, considering the signs, symptoms and histological changes in the lens, different stages of senile cataract may be compared to kaphaja timira, kacha and linganasha. In Kaphaja Kacha, the persons perceive Sun, Moon and Lamp as lustureless and dull, and Drishti mandala of eye appears as Svetha in color. Thus lakshanas of Kaphaja Kacha can be equated with signs and symptoms of Senile Immature Cataract.
Currently in conventional system of medicine, cataract surgery is the major available treatment. Owing to the increased incidence of senile cataract and possible complications and contra indications of surgery, research for the drugs that could effectively tackle the problem has arisen. Present study aims at evolving an effective measure to tackle this problem by employing Marichanjana explained in the text Basavarajiya by Nellakantakotturu Basavaraja in the chapter named Netra roga nidana lakshana chikitsadaya and Vachadi Kashaya internally described in the text Chikitsa sara sangraha by Vangasena in the chapter named Netra roga adhikara. Marichanjana containing Maricha, Amalaki, Karanja bija and Bringaraja toya are kaphahara and chakshushya. Vachadi kashaya containing Vacha, Trivrit, Chandana, Guduchi, Kirata tikta, Nimba, Haridra and Vasa, are kapha-pitta hara, lekhaniya and chakshushya. Hence, they are effective in kaphaja kacha. Also, they are feasible and affordable. Considering all these facts, the work has been taken up.
HYPOTHESIS:
Null hypothesis: H0 : Marichanjana and Marichanjana along with Vachadi Kashaya have no significant effect in Kaphaja Kacha.
Alternate hypothesis:
H1 : Marichanjana has better effect than Marichanjana along with Vachadi Kashaya internally in Kaphaja Kacha.
H2 : Marichanjana along with Vachadi Kashaya internally has better effect than Marichanjana alone in kaphaja kacha.
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