| CTRI Number |
CTRI/2025/09/094885 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Study of Triphala, Shunthi, Nimba, Lodhra and Atarushaka Kwatha Aashchyotan 2drops four times a day In Kaphabhishyanda with special reference To Simple Allergic conjunctivitis. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study Of Efficacy Of Triphala, Shunthi, Nimba, Lodhra and Atarushaka Kwatha Aashchyotan in Kaphabhishyanda With Special Reference To Simple Allergic 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 |
Vd SWAPNALI RAMESH PATEKAR |
| Designation |
Pg Scholar |
| Affiliation |
Government Ayurvedic College And Hospital Nanded |
| Address |
shalakyatantra department government ayurved college vazirabad Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9421639562 |
| Fax |
|
| Email |
swapnalipatekar04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N. A .KHAN |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College And Hospital Nanded |
| Address |
Department Of Shalyakyatantra Government Ayurvedic College And Hospital Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9325607099 |
| Fax |
|
| Email |
dr.khan_na@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrN A KHAN |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College And Hospital Nanded |
| Address |
Department Of Shalyakyatantra Government Ayurvedic College And Hospital Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9325607099 |
| Fax |
|
| Email |
dr.khan_na@yahoo.com |
|
|
Source of Monetary or Material Support
|
| self sponsored, shalakyatantra department Government ayurved college nanded 431601 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
vdswapnali ramesh patekar |
| Address |
shalakyatantra department Government ayurved college and hospital nanded |
| Type of Sponsor |
Other [self sponsored] |
|
|
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 |
| DrSWAPNALI RAMESH PATEKAR |
Government Ayurvedic College And Hospital Nanded |
Department of Shalakytantra government ayurved college vazirabad Nanded
Nanded
MAHARASHTRA |
09421639562
swapnalipatekar04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: daruharidra kwath with madhu, Reference: ashthang hruday, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: triphala shunthi nimb lodrha kwath , Reference: ashtang sanghrah uttartantra 19/61, Route: Ocular, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: qid, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients with signs and symptoms of Simple Allergic
conjunctivitis /Kaphabhishyanda. - Patient of 10 to 50 years age group of either gender. - Patients willing for Treatment. - Uncomplicated Simple Allergic Con |
|
| ExclusionCriteria |
| Details |
Associated with other forms of allergic conditions like skin rash, allergic bronchitis,
Atopic and systemic allergic problems. - Cases complicated with superadded infections and corneal ulcers. - Patients not willing for treatment. - Other active infectious systemic disorders / Ophthalmic disord |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the role of Triphala, Shunthi, Nimba, Lodhra and Atarushaka Kwatha
Aashchyotan in Kaphabhishyanda With Special Reference To Simple Allergic
conjunctivitis. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To reduce symptoms of simple allergic conjunctivitis.
• To establish the efficacy of Triphala, Shunthi, Nimba, Lodhra and Atarushaka
Kwatha Aashchyotan in Kaphabhishyanda. |
14 days |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
30/09/2025 |
| 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="2"
Months="0"
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 a clinical study of efficacy of trihala,shunthi,nimb,lodhra,attarushak kwath aashchyotan in kaphaj abhishandya with special reference to simple allergic conjuctivitis ,kwath in the form of 2 drops qid for 14 days given to trial group while daruharidra kwath with madhu aashchyotan will be given for control group.The primary objective is to study the role of trial group drug to reduce the symptoms of simple allergic conjunctivitis. the data will be assessed for decreasing the symptoms like lacrimation,itching ,conjuctival congestion using gradation chart.the study will be conducted at our centre institute. |