| CTRI Number |
CTRI/2025/10/096556 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Shatavari Ghrita preparation and Clinical trial in Allergic Conjunctivitis |
|
Scientific Title of Study
|
Evaluate the effect of Shatavari Ghrita in Simple Allergic Conjunctivitis a randomised controlled clinical 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 Rajay Govenkar |
| Designation |
PG Scholar |
| Affiliation |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahpur |
| Address |
Department of Shalakyatantra OPD No 27 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
9021212959 |
| Fax |
|
| Email |
rajgovenkar04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arunkumar B Biradar |
| Designation |
Professor |
| Affiliation |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahpur |
| Address |
Department of Shalakyatantra OPD No 27 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
9964064955 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arunkumar B Biradar |
| Designation |
Professor |
| Affiliation |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahpur |
| Address |
Department of Shalakyatantra OPD No 27 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
Belgaum
KARNATAKA
590003
India |
| Phone |
9964064955 |
| Fax |
|
| Email |
arunkumar.biradar@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Rajay Govenkar |
| Address |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahpur Belagavi Karnataka India 590003 |
| 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 Rajay Govenkar |
KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre |
Department of Shalakyatantra OPD No 27 KAHER s Shri B M Kankanawadi Ayurveda Mahavidyalaya Hospital and Research Centre Shahapur
Belgaum
KARNATAKA |
09021212959
rajgovenkar04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H109||Unspecified conjunctivitis. Ayurveda Condition: ABISHYANDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Olopatadine Hydrochloride | Eyedrop Olopatadine Hydrochloride Ophthalmic Solution Ip 0.1 percent | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavari Ghrita, Reference: Bharat bhaishajya ratnakara Shri Nagidas changbal Shah rasavaidyena B Jain Publishers Ghrita Prakarana Shakaradi 6369(Shatavari Ghritam)10 pg 46 and 2. Dr J L N Sastry (2005) Dravya Guna Vignana (Vol-2) 2nd Edition Chaukhambha Orientalia Publications p 438, Route: Topical, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects presenting with signs and symptoms of Simple Allergic Conjunctivitis and fulfilling the diagnostic criteria
Diagnostic Criteria
Patient of simple allergic conjunctivitis with the established signs & symptoms of Itching Redness Oedema & Watering with eosinophilia will be subjected for detailed anterior segment examination using slit lamp biomicroscope for diagnosis
|
|
| ExclusionCriteria |
| Details |
Subjects of other forms Allergic Conjunctivitis like Vernal keratoconjunctivitis Atopic keratoconjunctivitis Giant papillary Conjunctivitis drug or material sensitivity
Subjects having severe conditions of ocular surface disorders
Subjects having complicated eye diseases like Trachoma Trichiasis Steven Johnson Syndrome will be excluded
Subject suffering from Bacterial Chlamydial Parasitic and all other types of Conjunctivitis (contagious & non contagious)
Subjects suffering from Corneal Ulcers Opacities Trauma Foreign bodies
Diagnosed cases of Conjunctival epitheliopathies like pterygium pseudo-pterygium Tumours Retention cysts
Subjects having of Glaucoma Retinopathies Optic Neuritis and who are under long term topical ocular drug therapies for any Ophthalmic infective conditions
Extremely debilitated subjects Pregnant ladies Lactating ladies those who are working with on screen professions
Diagnosed cases of specific systemic disorders like Renal pathologies Uncontrolled Diabetes Uncontrolled Hypertension Hyperlipidemia Cardiovascular diseases |
|
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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 effect of Shatavari Ghrita in Simple Allergic Conjunctivitis |
DAY 0th (Before Treatment)
DAY 21 (After Treatment)
DAY 36 (Follow Up)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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
|
It is a type 1 Hypersensitivity reaction to exogenous allergens. Prevalence is 12.22 percent More in males 13.44 percent than in females 10.71 percent It is a mild non-specific inflammation of the Conjunctiva with symptoms of Itching Redness Oedema and increased lacrimation without any known specific aetiology This condition is not curable and therefore management is structured around the control of symptoms and prevention from factors exaggerating the symptoms DISEASE REVIEW It is a type 1 Hypersensitivity reaction mediated by IgE play an important role and other pathophysiological mechanism involved in inflammatory cascade In symptoms itching is most prominent redness watery secretion which is not purulent and a whitish discharge are characteristic Signs include redness lacrimation papillary hyperplasia of tarsal conjunctiva and lid swelling. Pathological features comprise of 3 responses namely Vascular Cellular Conjunctival response It has 2 forms viz. Seasonal (SAC) & Perennial (PAC) Allergic Conjunctivitis AIM Effect of Shatavari Ghrita in Simple Allergic Conjunctivitis OBJECTIVES Primary To evaluate the effect of Shatavari Ghrita in Simple Allergic Conjunctivitis Secondary To compare the effect of Shatavari Ghrita with control drug RESEARCH QUESTION Is Effect of Shatavari Ghrita and Olopatadine Hydrochloride Ophthalmic Solution Ip 0.1 percent comparable in the management of simple allergic conjunctivitis HYPOTHESIS H0 Effect of Shatavari Ghrita is not comparable in Simple Allergic Conjunctivitis H1 Effect of Shatavari Ghrita is comparable in Simple Allergic Conjunctivitis Expected
Outcome The results of Shatavari Ghrita and Eye Drop Olopatadine Hydrochloride Ophthalmic Solution Ip 0.1 percent are
comparable |