| CTRI Number |
CTRI/2023/08/056376 [Registered on: 10/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Evaluate The Efficacy of Dhatrayadi Rasakriya and Triphaladi Ghana Vati In Kacha With Special Reference To Immature Senile Cataract |
|
Scientific Title of Study
|
A Randomized Clinical Trial To Evaluate The Efficacy of Dhatrayadi Rasakriya and Triphaladi Ghana Vati In Kacha With Special Reference To Immature Senile Cataract |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandini miri |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Shalakya Tantra National Institute of Ayurveda Jaipur Rajasthan 302002
Room no 314 Department of Shalakya Tantra National Institute of Ayurveda Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9753815977 |
| Fax |
|
| Email |
nandinimiri4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Sharma |
| Designation |
Associate professor |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Shalakya Tantra National Institute of Ayurveda Jaipur Rajasthan 302002
Rooom 312 Department of Shalakya Tantra National Institute of Ayurveda Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
8955688129 |
| Fax |
|
| Email |
appu07@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nandini miri |
| Designation |
Pg Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Shalakya Tantra National Institute of Ayurveda Jaipur Rajasthan 302002
Room no 314 Department of Shalakya Tantra National Institute of Ayurveda Jaipur Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9753815977 |
| Fax |
|
| Email |
nandinimiri4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra National Institute of Ayurveda Jaipur, Jorawar Singh gate Rajasthan 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
Department of Shalakya Tantra National Institute of Ayurveda Jaipur, Rajasthan 302002 |
| Type of Sponsor |
Government 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 Nandini Miri |
National Institute of Ayurveda Jaipur |
Department of Shalakya Tantra National Institute of Ayurveda Jaipur Rajasthan 302002
Jaipur
RAJASTHAN |
9753815977
nandinimiri4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, National Institute of Ayurveda, Jaipur |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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|
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Triphaladi ghana vati, Reference: yogaratnakar netraroga chikitsa 1-2, Route: Oral, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 500(mg), Frequency: bd, Bhaishajya Kal: 45 Days, Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Procedure | - | rasakriyA, रसकà¥à¤°à¤¿à¤¯à¤¾ | (Procedure Reference: chakradatta netraroga chikitsa 140, Procedure details: rasakriya should used as Aschyotan 2drops bd)
(1) Medicine Name: Dhatrayadi Raskriya, Reference: chakradatta netraroga chikitsa 140, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 45 Days |
|
|
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Inclusion Criteria
|
| Age From |
40.00 Day(s) |
| Age To |
70.00 Day(s) |
| Gender |
Both |
| Details |
1) Age: 40-70 years
2) Patients having specific signs and symptoms of Kacha (Immature Cortical and Posterior Subcapsular Senile Cataract)
3) Patients with visual acuity 6/9 or less
4) Patients of either gender.
|
|
| ExclusionCriteria |
| Details |
1) Senile Mature and Hyper Mature Cataract
2) Visual acuity of less than 6/60
3) Congenital, developmental, traumatic, complicated and metabolic cataract.
4) Any other ocular pathology that can cause diminution of vision.
5) Any other systemic illness like HTN, DM
6) Person undergoing treatment for any other serious illness.
7) Patient unwilling to participate in the trial.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in best corrected visual acuity |
At baseline day and after completion of trail |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Cataract Grading Classification as per LOCS III |
At baseline day and after completion of trail |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/08/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/08/2023 |
| 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
|
Various
medicines are mentioned in Ayurvedic classics for vision care and prevention of
cataract. Among these lekhana Anjana is one of the topical treatments used in kacha.
Considering this point, Dhatrayadi Rasakriya Anjana was selected. It contains Amalaki,
Rasanjana, Madhu and Ghrita, having the lekhaneeya and kaphaghna properties. It
is indicated in Timira and Patalagata Rogas, also suitable for the management
of Kacha. Triphaladi Churna is mentioned by Acharya Yogaratnakara in the
management of Kacha. It contains drugs with chakshusya, and Rasayana action
like Amalaki, Haritaki, Vibhitaki, Yastimadhu and Lauha Bhasma.
NEED
FOR STUDY Cataract is the world leading cause of blindness affecting usually in
adults aged above 50 years as per data published in 2020, with over 15 million
individuals contributing to 45 percent of 33·6 million cases of global
blindness. Till date no accepted medical treatment is available for cataract,
surgery is the only available treatment for cataract. Therefore, the entire
world is looking at the other systems of medicine to tackle the situation and
looking upon preventive ophthalmology for improving and maintaining vision
RESEARCH QUESTION
Whether Dhatrayadi Rasakriya with or without Triphaladi Ghana Vati are equally
effective in Kacha w.s.r. to Immature Senile Cataract? HYPOTHESIS Null Hypothesis: Ho - There is no difference in the effect of Dhatrayadi Rasakriya with or
without Triphaladi Ghana Vati in Kacha. Alternative Hypothesis: H1 - There is difference in the effect of Dhatrayadi Rasakriya with
or without Triphaladi Ghana Vati in Kacha.
AIMS
AND OBJECTIVES
AIM
To evaluate the effect of Dhatrayadi Rasakriya
with or without Triphaladi Ghana Vati in Kacha w.s.r to Immature Senile
Cataract.
OBJECTIVES
1) To evaluate the effect of Dhatrayadi
Rasakriya with Triphaladi Ghana Vati in signs and symptoms of Kacha w.s.r to
Immature Senile Cataract.
2) To evaluate the effect of Dhatrayadi
Rasakriya in signs and symptoms of Kacha w.s.r. to Immature Senile Cataract.
3) To evaluate the changes in Cataract Grading
Classification as per LOCS III.
GROUPING OF PATIENTS : Group A- This group will be treated with Dhatrayadi Rasakriya topically along with
Triphaladi Ghana Vati orally for 45 days (Trial Group A)
Group B- This group will be treated with only Dhatrayadi Rasakriya topically for 45 days
(Trial group B)
ASSESSMENT CRITERIA:
1. Avyakta Darshana (Durastha and Samipastha) 2. Glare 3. Visualization of nonexisting thing like dots, lines, threads. 4. Best Corrected Visual Acuity for distance using Snellen’s chart 5. Best Corrected Visual Acuity for near using Jaeger’s Eye chart
6. Slit lamp examination with photography (if applicable) LOCS III cataract Grading will be followed for grading the cataract on the basis of slit
lamp findings.
Laboratory Investigation-
• CBC • RBS |