| CTRI Number |
CTRI/2025/06/089354 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic
Preventive |
| Study Design |
Other |
|
Public Title of Study
|
Ayurveda Treatment Protocol In Improving Visual Acuity In Dry Age-Related Macular Degeneration |
|
Scientific Title of Study
|
Effectiveness Of Selected Ayurveda Treatment Protocol In Improving Visual Acuity In Dry Age-Related Macular Degeneration |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjana Saji |
| Designation |
PG Scholar, Department Of Shalakyathanthra, Room no. 105, Government ayurveda college, Trivandrum |
| Affiliation |
Government Ayurveda College, Trivandrum |
| Address |
Sreenilayam, Vattathamara P.O, Kadakkal, Kollam
Thiruvananthapuram
KERALA
691536
India |
| Phone |
8590904006 |
| Fax |
|
| Email |
anjanasajikmr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. S Sunilkumar |
| Designation |
HOD, Department of Shalakyathanthra, Room no.105, Govt. Ayurveda College, Trivandrum |
| Affiliation |
Government Ayurveda College, Trivandrum |
| Address |
Anjanam, Edakulangara P.O, Kollam
Kollam
KERALA
691536
India |
| Phone |
8590904006 |
| Fax |
|
| Email |
drsunilsalakya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjana Saji |
| Designation |
PG Scholar, Department Of Shalakyathanthra, Room No. 105, Government Ayurveda College, Trivandrum |
| Affiliation |
Government Ayurveda College, Trivandrum |
| Address |
Sreenilayam, Vattathamara P.O, Kadakkal, Kollam
Kollam
KERALA
691536
India |
| Phone |
8590904006 |
| Fax |
|
| Email |
anjanasajikmr@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anjana Saji |
| Address |
Sreenilayam, Vattathamara P.O, Kadakkal, Kollam Pin: 691536 |
| 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 Anjana Saji |
Government Ayurveda College Hospital, Trivandrum |
Salakyathanthra department, OP, Room number 5
Thiruvananthapuram
KERALA |
08590904006
anjanasajikmr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC), Govt. Ayurveda College, Trivandrum |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H531||Subjective visual disturbances. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Ashtanga Hrudayam Sutrasthanam, Procedure details: The Participant Will Be Trained By Demonstrating The Procedure. In The
Morning, After Anjanam, The Participant Is Made To Lie Straight On His Back With Slight Lowering Of
The Head Extending Arms And Legs. Taila Is Taken In Sterile Dropper Bottle And Made Lukewarm.
1 ml (Standardized 0.5 ml- 1 Bindu) Will Be Instilled In Each Nostril Alternately, Keeping The Other One Closed. Done Once Daily.
)
(1) Medicine Name: Bhringaraja Thaila, Reference: Bhaishajya Rathnavali, Route: Nasal, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Duration: 90 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amalaka Rasayanam, Reference: Ashtanga Hrdayam Uttarasthanam, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Rasakadi Churnanjanam, Reference: Sharangadhara Samhitha, Route: Ocular, Dosage Form: Churna/ Powder, Dose: 125(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -Anjanam With Rasakadi Churnanjanam | | 4 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Bhringaraja thaila, Reference: Bhaishajya ratnavali, Route: Nasal, Dosage Form: Taila, Dose: 1(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically Diagnosed Participants Of Dry-ARMD With Blurring Of Vision, Distorted Vision, Scotoma, And
Metamorphopsia. Participants Between The Age Group Of 50-70 Years Irrespective Of Gender, Religion, And Socioeconomic Status. Participants With Visual Acuity Of 6/9 to 6/60(Log mar 0.2-1.00).Participants With Written Informed Consent. |
|
| ExclusionCriteria |
| Details |
A)Uncontrolled Hypertension Or Diabetes
B) Participants With Mature Cataract, High Myopia, Glaucoma, Other Retinal Degenerations
C) Participants With Systemic Illness Like Hypercholesteremia, Liver Disease, Renal Disease
D) Pigment Epithelium Detachment
E) Participants Who Are Not Co-operative
F) Participants With Any Other Macular Disease That Can Superimpose With ARMD
G) Participants Who Are Contraindicated For Prathimarsa Nasya
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement In Visual Acuity - Log MAR chart |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Amsler grid examination
2.Changes in the fundus
3.Changes in the OCT |
3 Months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
30/06/2025 |
| 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="1" |
|
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
|
Age-related macular degeneration (ARMD) is a degenerative disorder affecting the macula,
characterized by the presence of specific clinical findings, including drusen and RPE changes, in
the absence of another disorder. Heredity, nutrition, smoking, hypertension, exposure to sunlight,
hyperopia, and cataract particularly nuclear opacity have been proposed as risk factors in the
pathogenesis of ARMD. Common visual complaints of Dry-ARMD are mild to moderate gradual
loss of vision, distorted vision, seeing straight lines as wavy, bent, or fuzzy, and difficulty in near
work due to central shadowing. Current treatments include Vitamin, antioxidant supplementation,
intravitreal injection & photocoagulation. In Ayurveda, it can be taken as the saadam of
darsanendriya resulting from the depletion of dhatus in old age. The gradual progressive painless
loss of vision is the characteristic feature of pathology found in timira, kacha, linganasa. The
pathogenesis of Dry-ARMD suggests the involvement of Tridoshas predominantly Kapha- Vata
dosha. Thus, the basic treatment strategy adopted should be kapha vata samana, sodhana of
excess meda kapha, Chakshushya and Rasayana. Anjanam & nasyam are mentioned for samanya
thimira chikilsa in Ashtanga Hrdaya Uttara Sthana. Patients within the age group of 50 to 70
years diagnosed with Dry-ARMD will be selected based on inclusion criteria, attending OPD and
IPD of Shalakyatantra, Govt. Ayurveda College, Thiruvananthapuram will be subjected to
Rasakadi Churnanjanam, Bhringaraja Taila Prathimarsa nasya , and internal administration of
Amalaka Rasayana for 3 months. Clinical evaluation and investigations will be done before the
commencement of interventions and 3 months after treatment & follow-up will be done 1 month
after that. Results will be statistically analyzed after the study by one-way ANOVA test. |