| CTRI Number |
CTRI/2025/08/093143 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to evaluate the efficacy of Marma Chikitsa and Anu Taila Pratimarsha Nasya in the management of Shushkakshipaka (Dry Eye Syndrome) |
|
Scientific Title of Study
|
A comparative clinico-anatomical study to evaluate the efficacy of Marma Chikitsa and Anu Taila Pratimarsha Nasya in the management of Shushkakshipaka (Dry Eye Syndrome) |
| 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 Sona Rani |
| Designation |
PhD Scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
Department of Rachana Sharir, Government Ayurved, Yog and Naturopathy Integrated College, Bandra Bass mod, Rani Bazaar Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
8562877395 |
| Fax |
|
| Email |
sonurani2061@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakesh Kumar Sharma |
| Designation |
Associate Professor |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
Department of Rachana Sharir, Post Graduate Institute of Ayurveda and Research, Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9166216760 |
| Fax |
|
| Email |
rksharma69jumbo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sona Rani |
| Designation |
PhD Scholar |
| Affiliation |
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur |
| Address |
Department of Rachana Sharir, Government Ayurved, Yog and Naturopathy Integrated College, Bandra Bass mod, Rani Bazaar Bikaner
Bikaner
RAJASTHAN
334001
India |
| Phone |
8562877395 |
| Fax |
|
| Email |
sonurani2061@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurveda and Research, DSRRAU, Jodhpur (Rajasthan) India - 342037 |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurveda and Research,DSRRAU,Jodhpur |
| Address |
Post Graduate Institute of Ayurveda and Research, DSRRAU, Nagaur Road,Karwad,Jodhpur |
| Type of Sponsor |
Government 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 Sona Rani |
Government Ayurved,Yog and Naturopathy Integrated College,Bikaner |
OPD no.11, Department of Shalakya Tantra, Eye Divison, Government Ayurved,Yog and Naturopathy Integrated College,Bandra Bass Mod, Rani Bazaar, Bikaner (Rajasthan) - 334001
Bikaner
RAJASTHAN |
8562877395
sonurani2061@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Institute of Ayurved 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: SUSHKAKSHIPAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | pratimarSaH, प्रतिमर्श | (Procedure Reference: Sushruta Uttar Tantra-9/22, Procedure details: Individuals will receive Pratimarsha Nasya of Anu Taila, which involves instilling 2-2 drops of Anu Taila into each nostril once a day for the duration of 2 months.Follow up will be taken after one month. )
(1) Medicine Name: Anu Taila, Reference: Bharat Bhaishjya Ratnakar-Part-1 page no.65, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 2 Months | | 2 | Intervention Arm | Procedure | - | marmacikitsA, मर्मचिकित्सा | (Procedure Reference: MARMACHIKITSA-Basic Tenets in Ayurveda and Therapeutic Approaches- chapter-3 page-85-87, Procedure details: Procedure Reference: MARMACHIKITSA-Basic Tenets in Ayurveda and Therapeutic Approaches- chapter-3 page-85-87, Procedure details: Marma Chikitsa will be administered to the individuals, targeting specific Marma points including Apanga, Avarta & Shringataka Marma. The pressure will be given 15-18 times to each Marma point once a day for the duration of 2 months.Follow up will be taken after one month.)
|
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having symptoms of Shushkakshipaka according to Ayurveda classics as well as modern science.
2.Patient willing to take Nasya or Marma Chikitsa.
3.Person who will ready to sign the consent form. |
|
| ExclusionCriteria |
| Details |
1.Patients below the age of 16 years and above the age of 50 years.
2.Other type of Eye Disorders.
3.Patients with severe systemic disorders as uncontrolled Hypertension, Cardiac problem, Diabetes mellitus, Tuberculosis, Leprosy, Paralysis, malignant disease etc.
4.Pregnancy.
5.Use of other alternative medication during Ayurveda treatment.
6.Any pervious surgical history related to site of these Marmas.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome will be Improvement in clinical symptoms like Feeling of Dryness,foreign body sensation,Blurring of vision, Hardness of eyelids,Difficulty in opening and closing of eye,Burning sensation and Intolerance to light.
Outcome will be accessed after 2 months of intervention, follow up after every 15 days for 1 month. |
Baseline, after 2 months of intervention, follow up after every 15 days for 1 month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="0"
Months="3"
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
|
In India, limited epidemiological data is available on dry eye syndrome. Recently a study from north India reported 32% prevalence of dry eye syndrome there. Out of them 81% were having severe dry eye syndrome based on symptoms. Another study from south India reported 1.46% Dry eye syndrome incidences. The authors predicted that within the end of next decade, large number of urban and rural populations would have dry eye syndrome.Dry eye syndrome is more common among women than men. Many factors such as poor nutrition, prolonged screen time etc. results in dry eye. Vitamin A deficiency in children due to diseases like measles, respiratory tract infection etc. also results in dry eye.Tear substitutes are the only affordable treatment modality with modern medical science. The duration of action of these tear substitutes is variable and are advised as per the need, only providing symptomatic relief. The preservatives present in these formulations are also a cause of dry eye, whereas those available without preservatives are not cost-effective. so there arises the need for the approach from Ayurveda to manage and prevent the disease Migraine. A study will be conducted to evaluate the efficacy of Anu Taila Pratimarsha Nasya and Marma Chikitsa in the management of Shushkakshipaka (Dry Eye Syndrome ). The study will involve 100 individuals randomly assigned to two groups: Each group will consist of 50 individuals. Group A(Marma Chikitsa): - Marma Chikitsa will be administered to the individuals, targeting specific Marma points. Firstly Tila Taila will be applied and than 15-18 times pressure will be given to each Marma point once a day for duration of 2 month. . Group B (Anu Taila Pratimarsha Nasya): - Individuals in this group will receive Pratimarsha Nasya of Anu Taila, which involves instilling 2-2 drops of Anu Taila into each nostril once a day for duration of 2 months. Follow up will be taken after one month. |