| CTRI Number |
CTRI/2022/01/039084 [Registered on: 03/01/2022] Trial Registered Prospectively |
| Last Modified On: |
09/12/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic management in dry eye syndrome. |
|
Scientific Title of Study
|
EFFECT OF DURVA GHRITA ASHCHYOTANA, KSHEERABALA TAILA 21 PRATIMARSHA NASYA AND SHATAVARYADI CHURNA IN THE MANAGEMENT OF SHUSHKAKSHIPAKA (DRY EYE SYNDROME)-AN OPEN LABELLED DOUBLE ARM RANDOMIZED CONTROLLED CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jinoop P |
| Designation |
PhD Scholar |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Department Of Shalakyatantra, OPD No 110, First Floor, Hospital
Block, All India Institute Of Ayurveda, Sarita Vihar. New Delhi.
South
DELHI
110076
India |
| Phone |
7907459315 |
| Fax |
|
| Email |
drjinunarayan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narayan Bavalatti |
| Designation |
Associate professor |
| Affiliation |
All India Institute oAyurveda |
| Address |
Department Of Shalakyatantra, Fifth Floor, Administrative Block, All
India Institute Of Ayurveda, Sarita Vihar, New Delhi.
South
DELHI
110076
India |
| Phone |
9650715615 |
| Fax |
|
| Email |
eyenimi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Narayan Bavalatti |
| Designation |
Associate professor |
| Affiliation |
All India Institute oAyurveda |
| Address |
Department Of Shalakyatantra, Fifth Floor, Administrative Block, All
India Institute Of Ayurveda, Sarita Vihar, New Delhi.
South
DELHI
110076
India |
| Phone |
9650715615 |
| Fax |
|
| Email |
eyenimi@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Ayurveda |
| Address |
All India Institute Of Ayurveda, Gautampuri, Saritha Vihar,New Delhi,
110076
|
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jinoop P |
All India Institute of Ayurveda |
Department of
shalakyatantra,Eye OPD,Room
No 110, First floor,
hospital block,All India
Institute Of Ayurveda,
Saritha Vihar,New Delhi.
South
DELHI |
7907459315
drjinunarayan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H049||Disorder of lacrimal system, unspecified. Ayurveda Condition: SHUSHKAKSHIPAKA, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shatavaryadi churna, Reference: Yoga Ratnakara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu and grita), Additional Information: | | 2 | Intervention Arm | Procedure | - | ashchyotana | (Procedure Reference: Susruta Samhita, Procedure details: 1drop evening per day for 30 days)
(1) Medicine Name: Durva grita, Reference: Ayurveda pharmacopia of India-Trivandrum Publications, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: od, Duration: 30 Days | | 3 | Intervention Arm | Procedure | - | Pratimarshanasya | (Procedure Reference: Ashtanga Hridaya, Procedure details: 2drops morning for 30 days.)
(1) Medicine Name: Ksheerabala 21 A, Reference: Bhavaprakasha, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 30 Days | | 4 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: triphaladi churna, Reference: NA, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -madhu and grita), Additional Information: | | 5 | Comparator Arm | Procedure | - | Ashchyotana | (Procedure Reference: Susruta Samhita, Procedure details: 1 drop evening for 30 days)
(1) Medicine Name: shunthyadi grita, Reference: Anubhuta Yoga, Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(drops), Frequency: od, Duration: 30 Days | | 6 | Comparator Arm | Procedure | - | Pratimarshanasya | (Procedure Reference: Ashtanga Hridaya, Procedure details: 2 drops morning for 30 days)
(1) Medicine Name: Anutaila, Reference: Ashtanga Hridaya, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: od, Duration: 30 Days |
|
|
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Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing for the treatment.
Patients having the clinical features of shushkakshipaka (Dry eye syndrome).
Patients of 21-70 years having mild to moderate dry eye syndrome.
|
|
| ExclusionCriteria |
| Details |
The patients who are planning for ocular and/or lid surgeries within the study period
Patients having uncontrolled systemic disease like diabetes, hypertension etc.
Severe cases of dry eye syndrome with complications like corneal ulcer, Glaucoma Uveitis, etc.
Allergic and inflammatory conditions of eye like Acute conjunctivitis, Vernal keratoconjunctivitis, giant papillary conjunctivitis etc.
Patients on steroids, oral contraceptive pills, oestrogen replacement therapy or any other medication such as antispasmodic drugs like Atropine that may adversely affect the outcome of the study
H/o hypersensitivity to the trial drug or any of its ingredients.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in signs and symptoms of shushkakshipaka (dry eye syndrome)
•Comparative efficacy of group A with Group B
|
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Change in ocular health in terms of visual acuity.
2.Assessment of the trial drug for its pharmacognostical and phytochemical properties.
|
60 days |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
01/02/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Dry eye syndrome is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is also known as keratoconjunctivitis sicca (KCS) characterised by inflammation of the ocular surface and lacrimal glands. The symptoms include dryness of eyes, foreign body sensation, photophobia and redness.The present line of management of dry eye is regular use of lubricant eye drops/artificial tear which provides only symptomatic relief for short period. Shushkakshipaka is a similar disease explained in sarvakshigata roga. In the initial phase it is a vata predominant disease with pittanubandha. But if not properly managed it can lead to pittakopa causing paka of ocular tissue.Ayurveda envisage definite treatment for such clinical conditions. The general management of shushkakshipaka includes snehapana, nasya, seka, ashchyotana, tarpana etc. An attempt is made here to evaluate the efficacy of durva ghrita ashchyotana, ksheerabala taila 21Apratimarsha nasya along with shatavaryadi churna as oral medicine in the management of shushkakshipaka(dry eye syndrome). A study was conducted in ITRA, Jamnagar with shunthyadi ashchyotana, anutaila pratimarsha nasya and triphaladi yoga as oral medication in the management of shushkakshipaka(dry eye syndrome)which was found to be effective. Hence this protocol is taken as standard control in the study. |