CTRI

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CTRI Number

CTRI/2025/03/082094 [Registered on: 10/03/2025] Trial Registered Prospectively

Last Modified On:

29/05/2026

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda

Study Design

Other

Public Title of Study

Effect of laksha kashayam and mukkadi purampada in mild to moderate non proliferative diabetic retinopathy

Scientific Title of Study

Combined effect of laksha kashayam internally and mukkadi purampada externally in mild to moderate npdr

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sruthi P
Designation	PG Scholar
Affiliation	Government Ayurveda College Pariyaram Kannur
Address	Government Ayurveda College Pariyaram Kannur Kannur KERALA 670502 India
Phone	8606090411
Fax
Email	sruthisreedharanp@gmail.com

Details of Contact Person
Scientific Query

Name	Dr V K V Balakrishnan
Designation	HOD Department of Shalakyatantra
Affiliation	Government Ayurveda College Pariyaram Kannur
Address	Government Ayurveda College Pariyaram Kannur Kannur KERALA 670502 India
Phone	9447037892
Fax
Email	baluvkv@gmail.com

Details of Contact Person
Public Query

Name	Sruthi P
Designation	PG Scholar
Affiliation	Government Ayurveda College Pariyaram Kannur
Address	Government Ayurveda College Pariyaram Kannur Kannur KERALA 670502 India
Phone	8606090411
Fax
Email	sruthisreedharanp@gmail.com

Source of Monetary or Material Support

Government Ayurveda College Pariyaram Kannur

Primary Sponsor

Name	Sruthi P
Address	Government Ayurveda College Pariyaram Kannur
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sruthi P	Shalakyatantra OPD	Room No 8 Shalakyatantra OPD Government Ayurveda College Hospital Pariyaram Kannur Kannur KERALA	8606090411 sruthisreedharanp@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
institutional ethics committee government ayurveda college pariyaram kannur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:H36\|\|Retinal disorders in diseases classified elsewhere. Ayurveda Condition: KACAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: LAKSHA KASHAYAM, Reference: NA, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 45(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: -
2	Intervention Arm	Drug	Classical		(1) Medicine Name: MUKKADI PURAMPADA, Reference: SAHASRAYOGAM, Route: Topical, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 21 Days, Reference: Yes, Route: -MILK, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:

Inclusion Criteria

Age From	35.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	1 Participants in the age group 35-70 years, irrespective of gender. 2 Mild and moderate NPDR diagnosed on the basis of ETDRS criteria. 3 Participants with well controlled blood sugar level. (HbA1c less than 7mg/dl) 4 Participants willing to give consent

ExclusionCriteria

Details

1 Participants diagnosed with other retinal pathologies.
2 Participants diagnosed with NPDR associated with Chronic kidney disease, Chronic liver
disease.
3 Participants with diagnosed with NPDR associated with allergic skin diseases
4 Participants diagnosed with NPDR associated with ulcerative colitis, Crohn’s disease,
gastric ulcers.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
CHANGE IN VISION Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score value. CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and moderate NPDR Hard exudates Microaneurysms Dot and blot haemorrhages	CHANGE IN VISION Will be assessed by LogMAR visual acuity chart by noticing change in visual acuity score value. CHANGE IN OPTHALMOSCOPIC EXAMINATION- ETDRS grading of mild and moderate NPDR Hard exudates Microaneurysms Dot and blot haemorrhages

Secondary Outcome

Outcome	TimePoints
nil	nil

Target Sample Size

Total Sample Size="33"
Sample Size from India="33"
Final Enrollment numbers achieved (Total)= "33"
Final Enrollment numbers achieved (India)="33"

Phase of Trial

Phase 1

Date of First Enrollment (India)

01/04/2025

Date of Study Completion (India)

13/02/2026

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details
Modification(s)

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary
Modification(s)

Diabetic retinopathy refers to retinal changes seen in patients with Diabetes mellitus {1}. The underlying pathogenesis of diabetic retinopathy is local vascular endothelial growth factor production initiated by hyperglycemia induced capillary occlusion, which stimulates increased production of retinal vascular endothelial growth factors, increasing capillary permeability, retinal oedema, also stimulating angiogenesis, leading to new vessel formation.{2} The classification used in the Early Treatment Diabetic Retinopathy Study (ETDRS) is widely used internationally which divides it in to Non proliferative diabetic retinopathy(NPDR), proliferative diabetic retinopathy (PDR), Diabetic maculopathy and advanced diabetic eye disease. On the basis of severity NPDR is further classified as mild, moderate, severe and very severe NPDR. Conventionally, the management of mild and moderate NPDR is based on maintenance of control of glycaemia, lifestyle modification along with observation. Severe cases are treated through invasive techniques like intravitreal anti- VEGF drugs, intra vitreal steroids, laser therapy, macular photocoagulation, panretinal photocoagulation and surgical treatment. {3}The pathogenesis of prameha is extensive involving vitiated kapha along with the involvement of dhatus, namely, rasa, mamsa and medas along with kleda,sweda. As the prameha samprapti progresses , involvement of pittha and vata also involves resulting in paitika and vathika meha. {4} The aggrevated doshas,predominantly pitta under the influence of achakhushya nidana enters in to netra through oordwa gami siras and causes disease in different parts of the eye. {5} The global prevalence is 22.27% for diabetic retinopathy among participants with diabetes mellitus 6.17 % for vision threatening diabetic retinopathy and 4.07% for clinically significant macular edema (CSME) .Diabetic retinopathy is considered as the fifth leading cause of blindness.{6} The conventional treatments including anti VEGF are very expensive, invasive , has only poor outcome requires multiple administration within a short interval and risk of complications like endophthalmitis are high.{7} The intervention used in the study are the combination of laksha kashayam internally and mukkadi purampada externally in mild and moderate NPDR which have been clinically practiced in Shalakyatantra OPD of Government Ayurveda College Kannur for a long time. Laksha being a dravya with kashaya rasa, laghu snigda guna, seetha veerya , madhura vipaka . Bidalaka is a procedure where the medicated lepa is applied externally over the eyelids avoiding netra pakshma. The reference of Mukkadi purampada is in Sahasrayoga. The contents are predominantly having seetha veerya and pittaraktahara in nature. Mukkadi bidalaka is specifically mentioned in swelling, burning sensation, pain and congestion stages which makes it a suitable yoga in mild and moderate NPDR. The interventional study was conducted in the OPD of Shalakyatantra department of Government Ayurveda College Kannur in diagnosed cases of mild and moderate NPDR among patients aged 35-70 years. Statistical analysis was carried out by repeated ANOVA,Friedmann test and post hoc tests. Visual acuity, Dot and blot haemorrhages, microaneurysm showed statistically significant results where as result in hard exudates were less significant.