| CTRI Number |
CTRI/2026/01/102009 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study on the Neuroprotective Benefits of an Ayurvedic Treatment in Patients with Primary Open-Angle Glaucoma (Kaphaja Adhimantha) |
|
Scientific Title of Study
|
A randomized clinical trial to evaluate the neuroprotective effect of Ayurveda treatment protocol (AY/SHA/NIA/POAG/2024)as an adjuvant therapy in Kaphaja Adhimantha with special reference to primary open angle glaucoma |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kalpana Chhaniwal |
| Designation |
MS SHALAKYA TANTRA |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Shalakya Tantra,National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
6377702723 |
| Fax |
|
| Email |
k24chhaniwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Shamsa Fiaz |
| Designation |
Prof and HOD, Department of Shalakya Tantra |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
309, Department of Shalakya Tantra,National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
8764009846 |
| Fax |
|
| Email |
Shamsa_fiaz@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kalpana Chhaniwal |
| Designation |
MS SHALAKYA TANTRA |
| Affiliation |
National Institute of Ayurveda Jaipur |
| Address |
Department of Shalakya Tantra,National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road
Jaipur
RAJASTHAN
302002
India |
| Phone |
6377702723 |
| Fax |
|
| Email |
k24chhaniwal@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jaipur |
| Address |
National Institute of Ayurveda, Madhav Vilas Palace, Jorawar Singh Gate, Amer Road Jaipur (Rajasthan), Pin code 304001, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Kalpana Chhaniwal |
National Institute of Ayurveda Jaipur |
OPD 14, Department of Shalakya Tantra, NIA hospital
Jaipur
RAJASTHAN |
6377702723
k24chhaniwal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H401||Open-angle glaucoma. Ayurveda Condition: ADHIMANTHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | netratarpaNam, नेत्रतर्पणम् | (Procedure Reference: Chakradatta 60/54 , Procedure details: Medicine - Yashtyadhya Ghrita
Referance- Chakradatta
Route- Topical
Dosage form- Ghrita
Dose- 60 ml
Frequency - OD
Duration - 15 days
The periocular area is first cleaned with the help of luke warm water. Then a doe made up of black gram flour is applied around the eyes in circular manner. The height of the wall should be of 4 angula. Then luke warm ghee is poured slowly from inner canthus up to the level of eye lashes. The patient is instructed to blink the eyes slowly. The duration of tarpana is 1000 vakmatra (20 minutes). Then the ghee is taken out with the help of cotton & the doe is removed. )
(1) Medicine Name: Triphaladi Kwath, Reference: Chakradatta 59/45- 46, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 200(ml), Frequency: od, Duration: 6 Days(2) Medicine Name: Ksheerbala Tail , Reference: Sahasrayoga Taila Prakarana, Route: Nasal, Dosage Form: Taila, Dose: 12(drops), Frequency: od, Duration: 6 Days(3) Medicine Name: Triphala Churna , Reference: Bhavaprakasha Haritkyadi Varga 41-42) , Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Duration: 6 Days(4) Medicine Name: Netrashani Rasa , Reference: BHAISHAJYA RATNAVALI 64/219- 226, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Duration: 31 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | Standard control group with Anti Glaucoma medicines | Topical Eye drops
Timolol 0.25% Twice a day
Brimonidine 0.1% Twice a day
Dorzolamide 2% Twice a day occassionally |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1.All patients with primary open angle glaucoma who exhibit the signs and symptoms of Kaphaja Adhimantha, including Shopha, Srava and Shirahshula, Rupam Pashyati Dukhen
2.Patients aged between 30-70 years.
3.Best corrected visual acuity (BCVA) more than 6/60.
4.Patients with IOP in range between 22-30 mm of Hg.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1.Other types of glaucoma, including inflammatory, trauma-induced, exfoliative, pigmentary, and closed-angle glaucoma, as well as developmental glaucoma.
2.Glaucoma with hazy media that interferes with fundus examination and visual field mapping.
3.POAG with advanced stage of Optic atrophy with blindness.
4.Patients who have undergone Glaucoma surgery.
5.Patients who have undergone any ocular surgical intervention within 3 months.
6.Patients with any systemic illness which may affect the drug in clinical study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in pattern deviation in RNFL thickness through OCT |
From baseline to day 61 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Visual acuity and sign and symptoms of Kaphaja Adhimantha with special reference to Primary Open Angle Glaucoma |
From baseline to day 61 |
|
|
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)
|
01/09/2026 |
| 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="2"
Days="1" |
|
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
|
IntroductionGlaucoma is one of the leading cause of blindness in the world, marked by gradual damage to the optic nerve that leads to particular abnormalities in the visual field and alterations in the optic disc.Although high intraocular pressure (IOP) is frequently associated with it, the condition can still worsen even when IOP is under control.This illness is similar to Adhimantha, a Sarvagata Netra Roga which if left untreated, can result in Drishti Nasha, or vision loss. Visual impairment results from the progressive loss of retinal ganglion cells, which can cause problems in the central and peripheral visual fields. Increased outflow resistance, damages ganglion cell fibres, and is mostly caused by elevated IOP, however normal-tension glaucoma can also undergo similar alterations. Intervention Group A trial group purwa karma three sittings of purwa and pradhana larma along with Netrashani Rasa along with conservative treatment anti Glaucoma medicines Netra parisheka with Triphaladi Kwatha Marsh Nasya with Ksheerbala Tail Mridu virechana with Triphala churna Pradhana Karma Netra Tarpana with Yashtyadhya Ghrita
Group B Standard control group with Anti Glaucoma medicines
|