| CTRI Number |
CTRI/2025/04/085493 [Registered on: 24/04/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| 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 study the effect of Triphala Kwath internally in pittaj abhishyanda with special reference to Acute Bacterial Conjunctivitis |
|
Scientific Title of Study
|
Randomised open control clinical study to asscess the add on effect of Triphala Kwath Abhyantarpana with Moxifloxacin 0.5 percent eye drop in pittaj abhishyanda w.s.r to Acute 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 Sneha Sambhajirao Shinde |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Shalakya Tantra OPD Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329284011 |
| Fax |
|
| Email |
shindesneha225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekhar N Mule |
| Designation |
Head Of Department Shalakyatantra |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Shalakya Tantra OPD Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9175800710 |
| Fax |
|
| Email |
drcnm05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sneha Sambhajirao Shinde |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Shalakya Tantra OPD Kodoli Tal Panhala Dist Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
8329284011 |
| Fax |
|
| Email |
shindesneha225@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Sneha Sambhajirao Shinde |
| Address |
Shalakya Tantra OPD and IPD Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur |
| 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 Sneha Sambhajirao Shinde |
Yashwant Ayurvedic college PGT and RC Kodoli |
Shalakya Tantra OPD and IPD Second Floor Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli Tal Panhala Dist Kolhapur 416114
Kolhapur
MAHARASHTRA |
8329284011
shindesneha225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee Yashwant Ayurvedic College PGT and RC Kodoli Tal Panhala Dist Kolhapur Maharashtra India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H102||Other acute conjunctivitis. Ayurveda Condition: PITTABISHYANDAH, (2) ICD-10 Condition:H102||Other acute conjunctivitis. Ayurveda Condition: PITTABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Triphala Kwath, Reference: Vangsen Samhita , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Koshna Jal), Additional Information: add on effect of triphala kwath abhyantarpana with moxifloxacin eye drop | | 2 | Comparator Arm (Non Ayurveda) | | - | Moxifloxacin | Moxifloxacin 0.5% eye drop |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient of age group 18-60 years.
2) Irrespective of gender, religion, marital status etc.
3) Unilateral and bilateral Pittaj Abhishyanda
4) Patient with good compliance.
5) Patient having signs and symptoms of Acute Bacterial Conjunctivis.
|
|
| ExclusionCriteria |
| Details |
1) Patient having other than Acute Bacterial Conjunctivitis
2) Patient having corneal involvement.
3) Patient having K/C/O/ of any systemic diseases with complication which can lead to interfere with study.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the Add on effect of Triphala kwath abhyantarpana with moxifloxacin0.5% eye drop in Pittaj Abhishyandya W.S.R Acute Bacterial onjunctivitis. |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study Pittaj Abhishyandya in detail from various Ayurvedic Texts.
2) To Study the efficacy of Triphala Kwath Abhyantarpana and Moxifloxacin 0.5% eye drop in Signs of Daha, Dhumayana, Shishirabhinanda, Bhashpasamuchrya, Prapaka, Ushnaashruta, Pitak netrata in Pittaj Abhishyandya.
3) To access improvement by gradation of accessment criteria.
4) To study the modern view of Acute Bacterial Conjuctivitis in detail.
5) To review the literature about Kwath Abhyantarpana.
6) To achieve the outcome of study in 7 days. |
7 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
05/05/2025 |
| 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="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 an Randomized open control clinical trial to evaluate the efficacy of triphala kwath abhyantarpana in pittaj abhishyanda with special reference to acute bacterial conjunctivits. The assessment of signs and symptoms will be done at regular follow ups. Observation will be drawn from the outcomes achieved in 7 days. |