| CTRI Number |
CTRI/2023/10/058659 [Registered on: 13/10/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to see the Effect of Drakshadi Siddha Aschyotana in Pittaj Abhishyanda that is Conjunctivitis |
|
Scientific Title of Study
|
Randomized open controlled clinical trial to evaluate the efficacy of drakshadi siddha dugdha aschyotana 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 Ketan Krishna Dhainje |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
Opd no 2 Netra rog OPD Ground Floor Dhanvantari Ayurvedic Hospital Ashta Tal Walwa Dist Sangli
Opd no 2 Netra rog OPD Ground Floor Dhanvantari Ayurvedic Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9766508163 |
| Fax |
|
| Email |
ketand32@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Pournima Fasale |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
2nd Floor Department of Shalakyatantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9373079219 |
| Fax |
|
| Email |
pournimafasale33@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pournima Fasale |
| Designation |
Associate Professor |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
2nd floor Department of Shalakyatantra
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta
2nd floor Department of Shalakyatantra
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta
Sangli
MAHARASHTRA
416301
India |
| Phone |
9373079219 |
| Fax |
|
| Email |
pournimafasale33@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
|
|
Primary Sponsor
|
| Name |
Dr Ketan Krishna Dhainje |
| Address |
OPD no 2 Ophthalmology OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli |
| 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 Ketan Krishna Dhainje |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 2 Ophthalmology OPD Ground floor Dhanvantari Ayurved Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA |
9766508163
ketand32@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics 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 | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: Vagbhat sutra sthan 23/1 , Procedure details: Keep the patient in lying down, relaxed position.
With left hand open the left eye of the patient.
With the help of Pichu or Varti, instil the medicated drops at the inner
canthus from the distance of 2 angulas.
Depending upon Dosha, & disease determine the dose of drug and
retaining time.
Extra liquid should be soaked with clean & soft cloth.)
(1) Medicine Name: Drakshadi siddha dugdha , Reference: Yogratnakar netrarog chikitsa page 288, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 12(drops), Frequency: od, Duration: 2 Days | | 2 | Comparator Arm | Procedure | - | AScyotanam, आशà¥à¤šà¥à¤¯à¥‹à¤¤à¤¨à¤®à¥ | (Procedure Reference: vagbhat sutra sthan 23/1, Procedure details: Keep the patient in lying down, relaxed position.
With left hand open the left eye of the patient.
With the help of Pichu or Varti, instil the medicated drops at the inner
canthus from the distance of 2 angulas.
Depending upon Dosha, & disease determine the dose of drug and
retaining time.
Extra liquid should be soaked with clean and soft cloth.)
(1) Medicine Name: Nimbpatra swaras , Reference: Yogratnakar netrarog chikitsa page 388, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 12(drops), Frequency: od, Duration: 2 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Shows symptoms of Acute Mucopurulent Conjunctivitis
2 Patient with age above 18 years
3 Patient irrespective of Gender educational socioeconomic marital and caste status |
|
| ExclusionCriteria |
| Details |
1 Any other active acute infective ocular disease
2 Recently operated eye
3 Patient having systemic disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Drakshadi Siddha Dugdha Aschyotana in Pittaj Abhishyanada with special reference to Acute Mucopurulent Conjunctivitis. |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review the literature of Pittaj Abhishyanda & Acute Mucopurulent
Conjunctivitis.
To study the adverse effects of Drakshadi Siddha Dugdha Ashchyotana in
Pittaj Abhishyanda with special reference to Acute Mucopurulent
Conjunctivitis if there any. |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
20/10/2023 |
| 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
|
As we see the number of patients suffering from Acute mucopurulent conjunctivitis are increasing nowadays due to pollution and exposure to various organisms So in this study we are going to evaluate the efficacy of Drakshadi Siddha Dugdha Aschyotana in case of Pittaj Abhishyanda with special reference to Acute Mucopurulent Conjunctivitis Drakshadi Siddha Dugdha Aschyotana will be done 12 bindu retained for 300 matras for two days in the afternoon time in Trial group In control group Nimba patra swaras Aschyotana will be done 12 bindu retained for 300 matras for two days in the afternoon Both groups will be assessed on 10th and 15th day for signs and symptoms and effect will be noted |