| CTRI Number |
CTRI/2024/11/076106 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
30/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic treatment of Pterygium with Nayansukha Varti (eyedrop) and Pippalayadi Anjana (eyedrop). |
|
Scientific Title of Study
|
Comparative clinical evaluation of Nayansukha varti and Pippalayadi anjana in 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 |
Rashmi Bisht |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 1, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
06395639825 |
| Fax |
|
| Email |
rashmiaeir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jyoti Gupta |
| Designation |
Professor |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 1, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9997907340 |
| Fax |
|
| Email |
jyotiguptania@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Bisht |
| Designation |
PG Scholar |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
OPD 1, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL
249405
India |
| Phone |
06395639825 |
| Fax |
|
| Email |
rashmiaeir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan,Yogpeeth phase-1, Roorkee Road, Haridwar, Uttarakhand, India- 249405 |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar, Uttarakhand - 249405 |
| Type of Sponsor |
Private 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 Rashmi Bisht |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
OPD 1, Department of Shalakya-Tantra, Patanjali ayurved hospital,
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Phase
1, Roorkee road, Haridwar, Uttarakhand, India 249405
Hardwar
UTTARANCHAL |
06395639825
rashmiaeir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H110||Pterygium of eye. Ayurveda Condition: PRASTARI-ARMA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Yogaratnakara uttar., Procedure details: Drug Detail (Pippalayadi Anjana): Pippali (Piper longum Linn.), Haritaki (Terminalia chebula Retz.), Vibhitaki (Terminalia bellerica Roxb.), Amlaki (Emblica officinale), Laksha (Laccifera lacca Kerr.), Lodhra (Symplocos racemosa Roxb.), Saindha (rock salt), Bhrangraj (Eclipta alba Hassk.) all are taken in equal quantity.)
(1) Medicine Name: Pippalayadi Anjana, Reference: Yogaratnakara uttar., Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: qid, Duration: 30 Days | | 2 | Intervention Arm | Procedure | - | a~jjanam, अंजनमॠ| (Procedure Reference: Chakradutta 59/121, Procedure details: Drug Detail (Nayansukha Varti): Pippali (Piper longum Linn.):1 part, Haritaki (Terminalia chebula Retz.):2part.)))
(1) Medicine Name: Nayansukha Varti, Reference: Chakradutta 59/121, Route: Ocular, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 4(drops), Frequency: qid, Duration: 30 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 20-70 years, irrespective of gender who is willing to give informed consent will be included in study.
2. Patient with Primary Progressive Pterygium and those are not willing for surgery.
3. Clinical features as per Classics |
|
| ExclusionCriteria |
| Details |
1. Patient not willing for Trial
2. Age below 20 years and above 70 years
3. Patients having Clinical features of Adhimamsa and Snayu Arma.
4. Patients having ocular conditions like conjunctival cystic degeneration, Neoplastic changes like Epithelioma or Malignant Melanoma or
Fibrosarcoma.
5. Any inflammatory eye disease like Conjunctivitis, Dacryocytitis, Blepharitis, Corneal Ulceration etc.
6. Patients in which Pterygia is involving the pupillary area.
7. Patients those are contraindicated for Anjana. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment will be done on the basis of subjective and objective parameters |
Before and after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
SUBJECTIVE PARAMETERS-
1. Foreign Body Sensation (Gharsha)
2. Redness (Raga)
3. Lacrimation (Netrasrava)
4. Mamsa vriddhi (fleshy growth of conjunctival tissue)
5. Vascularity
OBJECTIVE PARAMETERS-
1. Length of whole Pterygium mass(mm)
2. Width of Pterygium mass at the neck(mm)
3. Visual Acuity (VA) |
Before and after treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2024 |
| Date of Study Completion (India) |
10/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This study is a Clinical Evaluation of Nayansukha Varti (eye drop) and Pipplayadi Anjana (eye drop) in Arma (Pterygium). This will be conducted on 60 patients from OPD/IPD of shalakya - Tantra Department of Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. Patients will be divided into two groups - 30 patients will be given Nayansukha Varti (eye drop) and other 30 patients will be given Pippalayadi Anjana ( eye drop). First follow up will be done 15 days after the anjana and second follow up will be done after 15 days of first follow up. Assessment will be done on the basis of subjective and objective parameters as discussed earlier. |