A Clinical trial to compare the efficacy of Elanir Kuzambu Anjana and Lauhadi guggulu in the management of Arma(Pterygium)
- Conditions
- Diseases of the eye and adnexa. Ayurveda Condition: Arma ,
- Registration Number
- CTRI/2025/04/084989
- Lead Sponsor
- National Institute of Ayurveda, Jaipur
- 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 them1*Shalakya 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.2*Acharya 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 *Sthana*as *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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
- The person with age of 18-60 years.
- Patients with sign and symptoms of Arma (Pterygium) will be selected irrespective of Sex, Religion and Profession.
- Clinical Features like White Fleshy Growth in Shukla mandala (white portion of eyes), foreign body sensation, and watering eyes.
- An Arma look like Alpa (small), Dadhinibha (curd-like), Nila (blue), Raktavarna (reddish), Dhusarvarna (dusty) and Tanu (Thin).
- Patient those are fit for Anjana karma According to Ayurveda text.
- Patient willing to register for trial.
- Patients below 18 years of age and Above 60 years.
- 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.
- Patients with severe Dry eyes, Recurrence of Pterygium 7.
- Chemical injury : e.g. Lime burn or any other Chronic ocular viral infection 8.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Length and width of Pterygium. 0,15th,30th and 60th day of enrollment
- Secondary Outcome Measures
Name Time Method Change in Foreign body sensation , visual Acuity & TBUT (Tear film break up time) 0,15th,30th & 60th day of enrollment
Trial Locations
- Locations (1)
National Institute of Ayurveda Hospital, Jaipur
🇮🇳Jaipur, RAJASTHAN, India
National Institute of Ayurveda Hospital, Jaipur🇮🇳Jaipur, RAJASTHAN, IndiaDr Pravesh Kumar VermaPrincipal investigator7014151630praveshv29@gmail.com