| CTRI Number |
CTRI/2025/04/084989 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical trial to compare the efficacy of Elanir Kuzambu Anjana and Lauhadi guggulu in the management of Arma(Pterygium) |
|
Scientific Title of Study
|
A Randomized Comparative Clinical Trial To Evaluate The Efficacy Of Elanir Kuzambu Anjana And Lauhadi Guggulu In The Management Of Arma (Pterygium) |
| 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 Pravesh Kumar Verma |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda , Deemed To be University (De Novo), Jaipur |
| Address |
Department Of Shalakya Tantra, National Institute Of Ayurveda, Amer Road, Jaipur, 302002
Department Of Shalakya Tantra, National Institute Of Ayurveda, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7014151630 |
| Fax |
|
| Email |
praveshv29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajendra Kumar Soni |
| Designation |
Assistant Professor |
| Affiliation |
National Institute Of Ayurveda , Deemed To be University (De Novo), Jaipur |
| Address |
Department Of Shalakya Tantra, National Institute Of Ayurveda, Amer Road, Jaipur, 302002
Department Of Shalakya Tantra, National Institute Of Ayurveda, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9455067007 |
| Fax |
|
| Email |
vaidya.rajsoni@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pravesh Kumar Verma |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda , Deemed To be University (De Novo), Jaipur |
| Address |
Department Of Shalakya Tantra, National Institute Of Ayurveda, Amer Road, Jaipur, 302002
Department Of Shalakya Tantra, National Institute Of Ayurveda, Amer Road, Jaipur, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7014151630 |
| Fax |
|
| Email |
praveshv29@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda, Deemed to be university, Jaipur, 302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda, Jaipur |
| Address |
National Institute Of Ayurveda, Jorawar singh gate Amer Road, Jaipur, 302002
Department Of Shalakya Tantra, National Institute Of Ayurveda, Amer Road, Jaipur, 302002 |
| 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 Pravesh Kumar Verma |
National Institute of Ayurveda Hospital, Jaipur |
Department of Shalakya Tantra OPD, Room number 14 NIA Hospital block, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
7014151630
praveshv29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF AYURVEDA JAIPUR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H00-H59||Diseases of the eye and adnexa. Ayurveda Condition: Arma , |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Elanir Kuzambu Anjana, Reference: The Ayurvedic Formulatory Of India Part 1. Pg.No.200 Drugs No.13:1, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: Elanir Kuzambu Anjana will use for Netra Pratisarana Karma | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Lauhadi Guggulu, Reference: Prof. Siddhinandan Mishra, Yogaratnakara; Varanasi; Chaukhambha Sansthana, 2018, Chapter 67, Netra rogadhikar, Shloka no. 277, Page no. 971, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ghrita and Madhu (4 gm and 2 gm respectively)), Additional Information: |
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The person with age of 18-60 years.
2. Patients with sign and symptoms of Arma (Pterygium) will be selected irrespective of Sex, Religion and Profession.
3. Clinical Features like White Fleshy Growth in Shukla mandala (white portion of eyes), foreign body sensation, and watering eyes.
4. An Arma look like Alpa (small), Dadhinibha (curd-like), Nila (blue), Raktavarna
(reddish), Dhusarvarna (dusty) and Tanu (Thin).
5. Patient those are fit for Anjana karma According to Ayurveda text.
6. Patient willing to register for trial
|
|
| ExclusionCriteria |
| Details |
1. Patients below 18 years of age and Above 60 years.
2. An Arma which is very thick and look like a piece of skin covered over with fibers of flesh and nerves as one occurring on the Krishna-mandala. (The patients in which Pterygium covers the pupillary margin.)
3. Progressive pterygium
4. Pseudopterygium
5. Any other ocular pathologies like Abhisyanda, Adhimantha etc.
6. Patients with severe Dry eyes, Recurrence of Pterygium
7. Chemical injury : e.g. Lime burn or any other Chronic ocular viral infection
8. Pregnancy
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Change in Length and width of Pterygium. |
0,15th,30th and 60th day of enrollment |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Foreign body sensation , visual Acuity & TBUT (Tear film break up time) |
0,15th,30th & 60th day of enrollment |
|
|
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 |
|
Date of First Enrollment (India)
|
24/04/2025 |
| 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 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
|
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Brief Summary
|
TITLE : A Randomized Comparative Clinical Trial to Evaluate the Efficacy of Elanir kuzambu Anjana And Lauhadi Guggulu In the Management of Arma (Pterygium) Background : Ayurveda is known as Ashtanga Ayurveda (A science with eight branches) &Shalakya Tantra is one of them1Shalakya Tantra deals with the diagnosis and management of Urdhwajatrugata Rogas (diseases occurring above the clavicle). Viz. Diseases of eyes, ears, nose, throat,oral cavity, head and neck.2Acharya Vagabhatta quoted that this beautiful world is of no use for a blind, however healthy he may be, because day and night are same for him. So, one should always strive hard to preserve his vision life-long.3 So, any disorder which hampers the eyesight directly should be in priority for the treatment. Acharya Sushruta has mentioned 76 Netra Rogas which are further divided according to their respective Sthanaas Sandhigata 09, Vartmagata 21, Shuklagata 11, Krishnagata 04, Sarvagata 17 and Drishtigata 12.4 Among them Arma is mentioned under 11 types of Shuklagata Netrarogas.5 Arma (Pterygium) is a Netra Shuklagata Vyadhi characterized by MamsaPratichaya (growth of tissue) in Shuklamandala, which progresses towards the Krishna mandala (cornea). Arma is classified into 5 different types: Prastari Arma, Shukla Arma, Lohita Arma, Adhimamsa Arma, and Snayu Arma.6 Pterygium is a triangular fibro-vascular growth of degenerated conjunctival tissue. Pterygium appears on nasal side, or rarely on temporal side of the cornea. Sometimes, both temporal and nasal side involved (double-headed pterygium).According to modern science Pterygium divided as Regressive and Progressive Pterygium.7 Classically, a pterygium has four parts: (1) Head – a blunt apex, (2) Cap- a few infiltrates in front of the apex (3) Neck- a limbal part, and (4) Body- a bulbar portion extending between the canthus and the limbus.8
NEED OF STUDY & HYPOTHESIS : Pterygium is a response to prolonged effect of environmental factors such as hot and dry weather, dusty atmosphere, exposure to sunlight (ultraviolet rays), dry heat, high wind and abundance of dust can easily produce disease like pterygium, pinguecula, xerosis etc. Arma is a common ocular surface disease which cause defective vision, when it encroaches the pupillary area and cosmetic issues. The clinical aspects and the treatment options have been studies since many years, but uncertainties still exist. Simple Pterygium excision is associated with a high rate of reoccurrence (About 33- 45%) often with more aggressive behavior then the original lesion.10 Considering its high cost for surgery and high recurrence rate after surgical excision, the present study has been selected. HYPOTHESIS : Null Hypothesis (H0)– Elanir Kuzambu Anjana and Lauhadi Guggulu are not effective in the management of Arma (Pterygium). Alternative Hypothesis (H1)– Elanir Kuzambu Anjana and Lauhadi Guggulu are effective in the management of Arma (Pterygium). Grouping : In the present trial, 40 clinically diagnosed patients of Pterygium (Arma) will be selected and randomly divided into two groups (20 patients in each group): Group A- This group will be treated with Elanir Kuzambu Anjana and Lauhadi Guggulu for 30 days. Group B- This group will be treated with Elanir Kuzambu Anjana for 30 days.
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