| CTRI Number |
CTRI/2024/07/071290 [Registered on: 25/07/2024] Trial Registered Prospectively |
| Last Modified On: |
16/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see the effect of lodhradi seka in the raktaj abhishyanda that is conjunctivitis |
|
Scientific Title of Study
|
A Single Arm Clinical Study to Evaluate the Efficacy of Lodhradi Seka in Raktaj Abhishyanda with special reference to Bacterial Conjunctivitis |
| 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 Nirmal Nitin Godbole |
| Designation |
PG Scholar |
| Affiliation |
LRP AYURVEDIC COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH CENTRE,URUN ISLAMPUR |
| Address |
Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PGT And Research Centre Islampur Sangli
INDIA
Opd No 10 Shalakya Department Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PGT And RC Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9767989988 |
| Fax |
|
| Email |
nirmalgodbole@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pravin Vitthal Chavan |
| Designation |
HOD |
| Affiliation |
LRP AYURVEDIC COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH CENTRE,URUN ISLAMPUR |
| Address |
Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PGT And Research Centre Islampur Sangli
INDIA
Opd No10 Shalakya Department Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PGT And RC Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9623318318 |
| Fax |
|
| Email |
drpravin222@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nirmal Nitin Godbole |
| Designation |
PG Scholar |
| Affiliation |
LRP AYURVEDIC COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH CENTRE,URUN ISLAMPUR |
| Address |
Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PGT And Research Centre Islampur Sangli
INDIA
Opd No10 Shalakya Department Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PGT And RC Islampur Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9767989988 |
| Fax |
|
| Email |
nirmalgodbole@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PG institute And Research Centre Islampur Sangli INDIA 415409 |
|
|
Primary Sponsor
|
| Name |
Dr Nirmal Nitin Godbole |
| Address |
Opd No10 Shalakya Department Loknete Rajarambapu Ayurvedic Medical Collage And Hospital, PGT And RC Islampur Sangli India 415409 |
| 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 |
| DRNIRMAL GODBOLE |
LRP Ayurvedic Medical Collage And Hospital Islampur Sangli |
OPD 10 SHALAKYATANTRA LRP
AYURVEDIC COLLEGE AND HOSPITAL PG INSTITUTE AND RESEARCH
CENTRE,URUN ISLAMPUR Sangli
MAHARASHTRA India
Sangli
MAHARASHTRA |
9767989988
nirmalgodbole@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| LRP Ayurvedic College Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sekaH, सेकः | (Procedure Reference: Sharangdhar Uttertartantra 13/2, Procedure details: To avoid the anxiety, the procedure will explain to them. Seka will perform in a place having sufficient light & devoid of direct blowing winds and dust. Patient will asked to lie comfortably in supine position on a table and eyes will be cleaned using sterile cotton swab. The patient will ask to relax and maintain the supine position on the table. The eye of the patient will close and Lodhradi Seka will be drop on the eyes from a distance of 4 fingers.
After performing the Seka, eyes will be cleaned with sterile cotton cloth. After this procedure, patient will asked to open eyes slowly. The patient will advised to avoid to expose wind, sun, dust, not to looking minute or bright objects and to follow hygienic measures)
(1) Medicine Name: Lodhradi seka, Reference: vangsen 36,95, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 100(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing the classical sign and symptoms of Raktaj Netra Abhishyanda will be selected for the study.
2. Patients of age group above 10 years and below 50 yrs Will be selected for the study.
3. Patients irrespective of sex, occupation and socio-economic status will be selected |
|
| ExclusionCriteria |
| Details |
1. Patients having disease other than Raktaj Abhishyanda.
2. Recently operated eye.
3. Patients having major complicated eye disease or systemic disease
4. Patients with Any malignant condition of eye.
5. Patient using any other eye medications |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To decreases the symptomes of redness watering
|
15 day study with follow up of
3rd,5th,7th,15th.(0,3,5,7,15) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of ayurvedic formulation |
15 day study with follow up of
3rd,5th,7th,15th.(0,3,5,7,15) |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/07/2024 |
| 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="6"
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
|
This is single arm clinical study in which ayurvedic formulation will be provided to 40 patients showing signs and symptoms of abhishyanda(bacterial conjunctivitis).Theage group taken for study trial will be between 10 years to 50 years.Ayurvedic formulations will be given on 0,3RD,5TH,7TH.15TH DAY .and The total duration of the study will 1 year and 6 months that is 18 months . According to Sushruta, Abhishyanda is a chief cause for various netrarogas. Abhishyanda is one among the seventeen types of sarvagata netra roga means affecting all parts of eyeball. It is of four types viz, vataja, pittaja, kaphaja, raktaja. The symptoms of Raktaj Abhishyanda are Lalima (Redness),Burning, Shotha, Pitt Strav from eye etc. According to modern ophthalmology Abhishyanda can be correlated with conjunctivitis. Conjunctivitis is inflammation of conjunctiva membrane . With increasing rate of population in the atmosphere, changing life styles and decreasing immunity some diseases are occurs rampantly. Among them, Raktaj Abhishyanda or conjunctivitis is more common. In view of the magnitude of the problem, the prevalence rate is higher in the society. Seka is mentioned as treatment modality in Raktaj Abhishyanda. In allopathic medicine conjunctivitis always managed with topical and systemic antibiotics to control infection and anti-inflammatory drugs. In ayurvedic literature - Vangsen NetraRogadhikarhas explained group of medicine as Seka in Raktaj Abhishyanda but there is no specific nomenclature, so for convenience it will named as "Lodhradi Seka". Hence, Evaluate the Efficacy of Lodhradi Seka in Raktaj Abhishyanda with special reference to Bacterial Conjunctivits - A Single Arm Clinical Study†has been selected. This study has been undertaken because we come across a number of patients of Netra Abhishyanda (conjunctivitis) in day to day practice, its incidence are increasing due to poor hygienic conditions, hot and dry climate, poor sanitation and overcrowding. In modern science, treatment for conjunctivitis is topical antibiotics drops, oral systemic antibiotics and anti-inflammatory and analgesic drugs. In Ayurveda for Raktaj Abhishyanda many dravyas are described in single form or in the form of kalpas. One of them is Lodhradi Seka which is described by Acharya Vangasen. |