| CTRI Number |
CTRI/2024/07/070795 [Registered on: 18/07/2024] 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 chandanadi bidalaka in pittaj abhishyanda that is conjunctivitis |
|
Scientific Title of Study
|
Single arm clinical study to evaluate the efficacy of chandanadi bidalaka in pittaj abhishyanda with special reference to acute mucopurulent 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 Sayali Tarachand Rathod |
| 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 |
9022988237 |
| Fax |
|
| Email |
saylirathod01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neeta Patil |
| Designation |
Associate Professor |
| 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 |
9527525654 |
| Fax |
|
| Email |
drneetapatil@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayali Tarachand Rathod |
| 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 RC Islampur
Sangli
INDIA
Opd No10 Shalakya Department Loknete Rajarambapu Ayurvedic Medical Collage and Hospital, PGT and RC Islampur
Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9022988237 |
| Fax |
|
| Email |
saylirathod01@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 Sayali Tarachand Rathod |
| Address |
OPD 10 SHALAKYATANTRA LRP Ayurvedic Medical Collage and Hospital, PGT and RC Islampur
Sangli
MAHARASHTRA 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 |
| DR SAYALI RATHOD |
LRP Ayurvedic Medical Collage and Hospital Islampur Sangli |
OPD 10 Shalakyatantra LRP Ayurvedic Medical Collage and Hospital, PGT and Research Centre Islampur
Sangli
Sangli
MAHARASHTRA |
9022988237
saylirathod01@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:H100||Mucopurulent conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | biDAlaka:, बिडालक: | (Procedure Reference: BHAVPRAKASH 159 NETRAROG 63, Procedure details: To avoid the anxiety, the procedure will explain to them. Bidalaka 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.
Pradhanakarma
The patient will ask to relax and maintain the supine position on the table. The eye of the patient will close and Chandanadi bidalka will applied on both eyelids leaving eyelash.
After performing the Bidalaka, the semi dried paste over the eyes will 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: CHANDANADI BIDALAKA, Reference: CHARAK CHIKITSA 26 PAGE NO 659, Route: Topical, Dosage Form: Lepa Churna, Dose: 10(g), 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 Pittaj 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 of age group below 10 years and above 50 yrs.
2. Patients with other occular disease.
3. Recently eye operated patients.
4. Patients with other major systemic diseases.
5. 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 days study with follow up of 3rd,5th,7th and 15th day (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 ( ACUTE MUCOPURULENT CONJUNCTIVITIS) . THE AGE 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 BE 1YEAR AND 6 MONTHS ,THAT IS 18 MONTHS.FINAL CONCLUSION WILL BE DRAWN ON THE BASIS OF STASTISTICAL METHODTropical countries like India has hot as well as cold and humid weather so there are more chances of occurrence of various eye Diseases. So its need of today to find the specific treatment of eye diseases, such as Abhishyanda 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. Our work place and its closer localities are full of industrial zone. Probably due to industrial pollution, lack of hygiene and climatic conditions good number of patients with Pittaj Abhishyanda (Acute Muco-Purulent Conjunctivitis) come to Shalakya tantra O.P.D. As we have to treat sample of patients with Netra Abhishyanda (conjunctivitis) in day to day practice of ophthalmology, we selected Abhishyanda for the purpose of study. Its incidences are increasing due to hot & dry climate, dirty habitat, unhygienic conditions, poor sanitation and pollution. Modern science treats conjunctivitis with topical antibiotic drops, systemic antibiotics orally and use of analgesic & anti-inflammatory drugs as per symptoms. Also these antibiotics do have serious side effects too. Ayurveda has given various easier and specific treatment procedures for Abhishyanda. Pittaj Abhishyanda is characterized by Daha, Prapak, shishirabhinanda, Dhumayana, Bashpasamucchaya, Ushnashruta, Netra pitata. And these lakshanas are very similar to Acute Mucopurulant Conjunctivitis as its Clinical features are: Discomfort, foreign body, blurring and redness of sudden onset (due to engorgement of vessels), Mild photophobia, i.e. difficulty to tolerate light. Mucopurulent discharge from the eyes. Sticking together of lid margins with discharge during sleep. Slight blurring of vision due to mucous flakes in front of cornea. The Management of this condition is based on various measures like Aschotan, Putpaka, Anjana, Dhoompan, Lepa, Bidalak. Among them we have selected Bidalak for the Study. |