| CTRI Number |
CTRI/2025/08/092944 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study effect of Dhatri Pindi on Pittaj Abhishynada |
|
Scientific Title of Study
|
Assessment of efficacy of Dhatri Pindi in Pittaj Abhishyanda:Randomised Controlled Trial |
| 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 Nikita Milind Rohokale |
| Designation |
PG Scholar |
| Affiliation |
PMTs Ayurveda College,Shevgaon |
| Address |
OPD NO 102 SHALAKYATANTRA DEPARTMENT,SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurveda College,Shevgaon Akhegaon road ,Tal.Shevgaon House no 21 Rohokale Lane ,Nalegaon,Ahmednagar Ahmadnagar MAHARASHTRA 414502 India |
| Phone |
8275446766 |
| Fax |
|
| Email |
rohokalenikita@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Swati Vishnu Sarwade |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurveda College,Shevgaon |
| Address |
OPD NO 102 SHALAKYATANTRA DEPARTMENT,SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurveda College,Shevgaon Akhegaon road ,Tal.Shevgaon
Ahmadnagar MAHARASHTRA 414502 India |
| Phone |
9422935125 |
| Fax |
|
| Email |
drsarwadeswativ@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Swati Vishnu Sarwade |
| Designation |
Professor and HOD |
| Affiliation |
PMTs Ayurveda College,Shevgaon |
| Address |
OPD NO 102 SHALAKYATANTRA DEPARTMENT,SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurveda College,Shevgaon Akhegaon road ,Tal.Shevgaon PMTs Staff Quarters,Ahekhgaon road Shevgaon Ahmadnagar MAHARASHTRA 414502 India |
| Phone |
9422935125 |
| Fax |
|
| Email |
drsarwadeswativ@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD NO 102 SHALAKYATANTRA DEPARTMENT,SHRI EKNATH AYURVED RUGNALAYA,PMTs Ayurveda College,Shevgaon Akhegaon road ,Tal.Shevgaon,Dit.Ahmednagar-414502 India |
|
|
Primary Sponsor
|
| Name |
PMTs Ayurveda College |
| Address |
Shevgaon Akhegaon road,Tal.Shevgaon,Dist.Ahmednagar,Maharashtra 414502 |
| Type of Sponsor |
Private medical college |
|
|
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 Nikita Milind Rohokale |
PMTs Ayurveda College, Shevgaon |
SHALAKYATANTRA DEPARTMENT, OPD
NO. 102 SHRI EKNATH AYURVED
RUGNALAYA, PMTs Ayurveda
College, Shevgaon Akhegaon road,
Tal. Shevgaon, Dist. Ahmednagar,
Maharashtra Ahmadnagar MAHARASHTRA |
8275446766
rohokalenikita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PMT/ACS/IEC- 12/SHLK 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: PITTABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
The patients presenting with signs and symptoms of Pittaj Abhishyanda (Netra
lalima, Kleda, Daah etc.).
Patients willing to give informed & written consent.
Irrespective of sex and Socioeconomics status.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from trachoma, dacrocystitis etc.
2. Patients with known case of HIV/Hbsag
3. Patients not willing for trial. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate efficacy of Dhatri Pindi Kalpna in Pittaj Abhishyanda. |
7 day treatment with 4 follo up 0,3,5 and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To review data related to Pittaj Abhishyanda and Pindi Kalpna in Ayurvedic texts.
To review data related to Bacterial Conjunctivitis in Modern texts.
To evaluate efficacy of Moxifloxacin eye drop in Pittaj Abhishyanda.
To compare efficacy between Dhatri Pindi Kalpna and Moxifloxacin in Pittaj
Abhishyanda.
To observe any Adverse Drug Reaction. |
7 day treatment with 4 follo up 0,3,5 and 7th day |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/08/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Abhishyanda is considered as Sarvagata Netraroga which is a dreadful disease and possess symptoms of conjunctivitis as per the modern science. The inflammation of conjunctiva mainly occurs in Abhishyanda which can spread through Rakta. Abhishyanda if not cured then it can causes Adhimanth associated with acute pain. The other complication may include, Sandhigat roga shuklagat roga, Krishnagat roga and Vartmagat roga, etc. Abhishyanda is put as disease amongst the seventeen Sarvagat rogas. Ayurveda classics mentioned various types of Abhishyanda including Vataja Abhishyanda, Pittaja Abhishyanda, Kaphaja Abhishyanda and Raktaja Abhishyanda. The disease involves Kledana in Doshas and Dhatu due to which profuse discharge comes out from the eye. Therefore excessive discharge from eye is the major feature of Abhishyanda. Ayurveda described different approaches such as Anjana, Pariseka, Pralepa, Aschyotana, Tarpana, Sweda ,Pindi ,Bidalak , and Putpaka for the management of various Netraroga. Some ayurveda formulations and herbs also offers relieves in the symptoms of Abhishyanda,In view of the magnitude of the problem, the discomfort it causes to the patients and the cost of the treatment, there is need to develop a therapy which is free from side effects, cheaper, and has a significant effect in alleviating the symptoms of the patients. As above mentioned kalpanas the Pindi Kalpna is the topic which remained untouched.there is no significant work done on Pindi Kalpna in today’s era hence ,This study is an attempt in this direction to evaluate the effects of Dhatri Pindi on mucopurulent conjunctivitis. However amongest the topical remedies the most simple,practical yet effective procedures giving better results in local inflammations and painful condition of the eye thereby giving an instant and immediate effect is Pindi kalpna,For Dhatri Phalam- The literary study of fruit Amalaki from Ayurvedic texts and modern researches concludes that fruit that is Embelica officinalis has following properties according to Ayurveda, Rasayana, Vrushya, Chakshushya, Panduhar, Krimihar, Udarhar, Vaysthapana, Pramehhar, Kamalahar, and according to modern Antioxidant, Anti-inflammatory,Antimicrobial,Analgesic, Anticancer, Hepatoprotective, Gastroprotective, Anticarcinogenic. |