| CTRI Number |
CTRI/2026/03/106754 [Registered on: 23/03/2026] Trial Registered Prospectively |
| Last Modified On: |
23/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic treatment of Immature Cataract |
|
Scientific Title of Study
|
A clinical consensus study for the development of Standard Operating Procedure and practice guidelines for Anjana Karma with a Feasibility study in immature cataract |
| 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 Shrawan Kumar Sahu |
| Designation |
Research Officer Ay |
| Affiliation |
Central Ayurveda Research Institute New Delhi |
| Address |
Room No 48, Ground floor, Block C, Central Ayurveda Research Institute Punjabi Bagh Road no 66, New Delhi, India
West
New Delhi
DELHI
110026
India |
| Phone |
7500799915 |
| Fax |
01125225546 |
| Email |
drsahu79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta Mata |
| Designation |
Research Officer Ay |
| Affiliation |
Central Ayurveda Research Institute New Delhi |
| Address |
ROOM NO 201,2ND Floor, OPD block Central Ayurveda Research Institute Punjabi Bagh Road no 66 New Delhi India
DELHI 110026 India
New Delhi
DELHI
110026
India |
| Phone |
8866014946 |
| Fax |
01125225546 |
| Email |
drshwetamataccras@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Praveen Balakrishnan |
| Designation |
Research Officer Ay |
| Affiliation |
Regional Ayurveda research Institute |
| Address |
Room No 224,Regional Ayurveda research Institute Poojappura Trivandrum
Poojappura Trivandrum
Thiruvananthapuram
KERALA
695012
India |
| Phone |
07012911654 |
| Fax |
|
| Email |
drpraveenbalakrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Ayurvedic Sciences 61-65 Institutional Area Janakpuri New Delhi |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Ayurvedic Sciences |
| Address |
61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi-110058 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sharwan Kumar Sahu |
Central Ayurveda Research Institute New Delhi |
ROOM NO 48, Ground Floor , Block C ,Central Ayurveda Research Institute Punjabi Bagh Road no 66, New Delhi India
West
DELHI
110026
India
New Delhi
DELHI |
7500799975
01125225546
drsahu79@gmail.com |
| Dr Praveen Balakrishnan |
Regional Ayurveda Research Institute |
Room No 224 ,Regional Ayurveda Research Institute
Poojappura, Trivandrum- 695012
Thiruvananthapuram
KERALA |
7012911654
drpraveenbalakrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| CentralEthicsCommittee |
Approved |
| CentralEthicsCommittee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H25||Age-related cataract. Ayurveda Condition: TIMIRAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | anjana | (Procedure Reference: sushrut samhita uttara tantra, Procedure details: Topical application of medicine to the internal surface of lid margin (conjunctival fornices) with an applicator (Anjana Shalaka) Treatment for first 7 days .)
(1) Medicine Name: chandrodya varti, Reference: AFI-Part-1,13/3, Route: Ocular, Dosage Form: Varti/ Suppository, Dose: 60(mg), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of age 40-70 years
2.Subjects who agree to participate in the study and submit a written informed consent form
3. Willing and able to participate for 1 week
4. Diagnosed cases of immature cataract who are not receiving any specific treatment.
|
|
| ExclusionCriteria |
| Details |
1.Subjects who have active corneal ulceration, corneal opacity, keratitis,trauma etc
2.Uncontrolled diabetes mellitus (DM) (HbA1c MORE THAN 8) and Uncontrolled hypertension (Systolic BP higher than 160mmHg and/or Diastolic BP higher than 100mmHg)
3.Subjects suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-endocrinal disorders, etc.)
4. Subjects with concurrent Hepatic Dysfunction (defined as AST and or ALT more than 2 times of the upper normal limit) or Renal Dysfunction ((defined as S. Creatinine above 1.2mg/dL or an eGFR below 60 mL/min/1.73 m2 ), uncontrolled Pulmonary Dysfunction (asthmatic and COPD subjects).
5. Alcoholics and/or drug abusers
6. Patients with evidence of malignancy
7.H/O Hypersensitivity to the trial drug or any of its ingredients
8. Subjects who have completed participation in any other clinical trial during the past six months.
9. Any other condition which the Investigator thinks may jeopardize the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Changes in visual acuity by Snellen’s Chart
[Change in at least 1 line]
|
baseline and after 7 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any SAE /ADR |
baseline and after 7 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/09/2026 |
| 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="1"
Months="0"
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
|
Non-surgical, non-invasive and cost-effective management of eye diseases is possible with the adoption of Ayurvedic procedures coupled with that of eye friendly diet habit, regimen and medicines. In Ayurveda, a specific ocular therapeutic procedure (a group of special methods of drug administration) for the treatment for eye disorders has been delineated in the name of kriyakalpa. Ancient medical scholars, the pioneers of Kriyakalpa were aware of the mechanism of blood aqueous barrier as well as ocular pharmacology. Kriyakalpa involves mucosal and cutaneous route of drug administration mainly. The Kriyakalpa has witnessed some changes in its number in due course of time, which indicates the progressive nature of Ayurveda. Acharya Charaka, Acharya Sushruta, Acharya Vagbhata, Acharya Sharangdhara etc. are some of the pioneers of Ayurveda. It is due to their tireless efforts that this ancient science is standing in this modern era of advanced technology for the welfare of the masses. Acharya Charak enumerated three kriyakalpa i.e. Aschyotana, Anjana & Bidalaka in his treatise Charaka Samhita. On the other hand, Acharya Sushruta described five kriyakalpas i.e Tarpana, Putapaka, Seka, Aschyotana & Anjana. Acharya Sharangdhara added two more kriyakalpa viz. Pindi &Bidalaka in that of Acharya Sushruta and made its number seven. A comprehensive description of Kriyakalpa is as follows. 1. Tarpana- This is one of the Kriyakalpa which brings about nourishing effect to the eyes to improve the visual acuity. In this procedure the unctuous substances i.e. medicated lipid (mostly Ghrita Manda) is kept in the eye for a specific period surrounded by a layer of wet flour of pulse (Phaseolus radiatus) or now a days by a Tarpana goggle. 2. Putapaka- Putapaka is the topical application of the extract in the eyes for a speculated time, which is performed after Tarpana therapy in order to restore the strength to eyes. The extract is prepared out of plant drugs, animal flesh, mineral drugs and fats by heating their mixture (paste) in a closed chamber. 3. Seka- This is the pouring of thin streams of medicated solution onto the closed eyes continuously from a height of four Angul for a specific period of time,as per the prevalence of Dosha(body humour). Seka is indicated in acute condition of eye diseases. 4. Aschyotana- Instillation of the drops of medicated solution into the open eyes from the height of two Angul is called as Aschyotana. Aschyotana is the first line of treatment in all eye diseases. 5. Anjana- Topical application of medicine to the internal surface of lid margin (conjunctival fornices) with an applicator (Anjana Shalaka) is called as Anjana. 6. Pindi- Here, heated medicine in cotton or Doshghna leaves is kept tightly over the eyelids. This is comparable to the Poultice. Pindi is capable of relieving the symptoms like oedema, itching and ocular pain. 7. Bidalaka- This is the application of medicated paste over the skin of lids and is useful in early stages of eye diseases especially for getting rid of burning, redness,watering, itching and swelling of eye. The judicious and superb use of Shalaka must have remained the central point behind the nomenclature Shalakya Tantra.Since use of Shalaka is mainly associated with Anjana and there is not an availability of SOP for Anjana till now,it is the need of the time to develop the same. The purpose of the current study is to scientifically standardize Anjana procedure. Standardization works in the field of Netra Kriyakalpa will ultimately contribute to redaction of procedures which is need of the hour
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