| CTRI Number |
CTRI/2025/07/091979 [Registered on: 30/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to see the effect of yastimadhu rasakriya anjana with and without parnayavani swarasa internally in allergic conjunctivitis |
|
Scientific Title of Study
|
An open label randomised comparative clinical study to evaluate the efficacy of yasthimadhu rasakriya anjana with and without parnayavani swarasa abhyantara prayoga in management of vataja abhishyanda w.s.r to 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 |
Dr Bharath R |
| Designation |
Post Graduate Scholar |
| Affiliation |
JSS Ayurveda Medical College and Hospital |
| Address |
OPD 5, Department of Shalakya Tantra, JSS Ayurveda Hospital,
41/E Lalithadripura Road, MYSURU, Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
8553838725 |
| Fax |
|
| Email |
bharath.ravi.798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sarbeswar kar |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
OPD 5, Department of Shalakya Tantra, JSS Ayurveda Hospital,
41/E Lalithadripura Road, MYSURU, Karnataka 570028
Mysore
KARNATAKA
570028
India |
| Phone |
9741197007 |
| Fax |
|
| Email |
drskar2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sarbeswar kar |
| Designation |
Professor |
| Affiliation |
JSS Ayurveda Medical College |
| Address |
OPD 5, Department of Shalakya Tantra, JSS Ayurveda Hospital,
41/E Lalithadripura Road, MYSURU, Karnataka 570028
KARNATAKA
570028
India |
| Phone |
9741197007 |
| Fax |
|
| Email |
drskar2007@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakya Tantra, JSS Ayurveda Hospital,
41/E Lalithadripura Road, MYSURU, Karnataka 570028 |
|
|
Primary Sponsor
|
| Name |
Dr Bharath R |
| Address |
Department of Shalakya Tantra, JSS Ayurveda Hospital, 41/E Lalithadripura Road, MYSURU, Karnataka-570028 |
| Type of Sponsor |
Other [] |
|
|
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 Bharath R |
JSS Ayurveda Hospital Mysuru |
Department of Shalakya Tantra, JSS Ayurveda Hospital, 41/E Lalithadripura Road, MYSURU, Karnataka 570028
Mysore
KARNATAKA |
8553838725
bharath.ravi.798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, JSS Ayurveda Medical College, Mysuru |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H102||Other acute conjunctivitis. Ayurveda Condition: VATAJA-NETRAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: susrutha uttaratantra 21, Procedure details: Purvakarma:
Stanika prakshalana with sudhajala.
Pradhana Karma:
Anjana with Yastimadhu Rasakriya 1 Vidanga matra twice a day from Day 1 to 7.
Parnayavani Swarasa 12ml twice a day orally from Day 1 to 7.
Paschatkarma:
Removal Of applied anjana after 12 hours)
(1) Medicine Name: Yastimadhu Rasakriyaanjana, Reference: Susrutha Uttaratantra, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(mg), Frequency: bd, Duration: 7 Days(2) Medicine Name: Parnayavani Swarara, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 12(ml), Frequency: bd, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | a~jjanam, अंजनम् | (Procedure Reference: Susrutha Uttara Tantra, Procedure details: Purvakarma: Stanika prakshalana with sudhajala. Pradhana Karma: Anjana with Yastimadhu Rasakriya 1 Vidanga matra twice a day from Day 1 to 7. Paschatkarma: Removal Of applied anjana after 12 hours))
(1) Medicine Name: Yastimadhu rasakriya, Reference: Susrutha Uttara Tantra, Route: Ocular, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 60(mg), Frequency: bd, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of age group 10-60 years selected irrespective of gender, religion.
Clinical features of Vataja Abhishyanadha
Subjects who fit for Anjana karma |
|
| ExclusionCriteria |
| Details |
Subjects with Infective Conjunctivitis, Corneal Ulcer, Trachoma, Dacryocystitis and
any other ocular symptoms.
Subjects with known case of uncontrolled diabetes HbA1c morethan 8.5% |
|
|
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 |
Reduction in the inflammation of conjunctiva
Absence of Eosinophils & Mast cells count in Conjunctival Smear |
22 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in Nistoda - Princking pain in eye
Reduction in Sangharsha- Foreign body Sensation
Reduction in Parushya -Rough occular surface
Reduction - Shishirashruta (Lacrimation |
22 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
10/08/2025 |
| 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="3"
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
|
Shalakya Tantra is the branch of Ayurveda that deals with sense organs. Among all the Indriya, Nayana is considered as pradhana Indriya. Vataja Abhishyanda is one among Sarvagata Netraroga that is explained by all Acharyas. Vataja Abhishyanda is considered as a root cause for all the diseases of Eye and if not treated leads to vision impairment and visual loss. Vataja Abhisyanda lakshanas can be compared with signs and symptoms of Allergic Conjunctivitis. Allergic Conjunctivitis is a prevalent ocular condition encountered frequently by ophthalmologists and cornea specialists, affecting up to 40% of the population. Despite its high prevalence, many affected individuals do not seek medical help, leading to under diagnosis and under treatment. Allergic conjunctivitis results from various factors, including genetics, inflammation, air pollution, pollen exposure and contact with pets[1]. Allergic Conjunctivitis prevalence has increased over the past decade, with recurrence 41-62%[2] making it one of clinical practice’s most frequently encountered conditions. Anjana is an ocular therapeutic procedure indicated in treatment of eye disorder. In Susrutha Samhita Uttaratantra Vataabhishyanda prathishedha adhyaya, Yastimadhu Rasakriya Anjana is indicated which contains Yastimadhu, Rajani, Patya, Devadaru, Aja dugdha[3], which has been explained as sresta(potent therapeutics) by Acharya Susrutha in the treatment of Vataja Abhisyandha. Yasthimadhu which is Chaksusya, Vatapittahara, Snidgha, Vrana hara, Varnya, Vrusya, Kesya, Shophahara[4]. It contains glycyrrhizic acid and glycyrrhizin which is proven as anti allergic and anti inflammatory[5] . Thus, it can be used in treating Vataja Abhishyanda (Allergic Conjunctivitis). Parnayavani(Coleus aromaticus) is vata kaphahara[6], it has anti inflammatory property, and used in Conjunctivitis[7] . The treatment for Allergic Conjunctivitis typically involves topical antihistamines, mast cell inhibitors and steroids. However, the long term use of medications leads to complications like Cataract and Open angle glaucoma. To avoid such complication it is necessary to explore the safe and effective medication for the management. Hence, in this study an effort is made to evaluate the effect of Yastimadhu Rasakriya Anjana and Parnayavani Swarasa abhyantara prayoga in the management of Vataja Abhishyanda and to prevent the recurrence, intermittent and persistent nature of the disease |