| CTRI Number |
CTRI/2021/04/033120 [Registered on: 26/04/2021] Trial Registered Prospectively |
| Last Modified On: |
23/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EFFECTIVENESS OF NEEDLE-PUNCTURE(VIDDHAKARMA) ALONG WITH ANTI-GLAUCOMA EYE-DROPS ON PAIN, VISION AND EYE-PRESSURE IN GLAUCOMA (KACHBINDU/ ADHIMANTHA). |
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Scientific Title of Study
|
A RANDOMIZED COMPARATIVE STUDY OF EFFECTIVENESS OF VIDDHAKARMA PLUS ANTI-GLAUCOMATOUS EYE-DROPS VERSUS ANTI-GLAUCOMATOUS EYE-DROPS ALONE IN ADHIMANTHA WITH REFERENCE TO GLAUCOMA. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chaitali Kulkarni |
| Designation |
PG Scholar |
| Affiliation |
Y.M.T. Ayurvedic Medical College and Hospital |
| Address |
Z-701, phase 2, Jalvayu Vihar
Sector-20, Kharghar, Navi Mumbai
Y.M.T. Ayurvedic Medical College and Hospital, Shalakya Tantra Department, Ground Floor, Institutional Area, Sector-4, Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9757398266 |
| Fax |
|
| Email |
ckkulkarni512@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nutan Radaye |
| Designation |
HOD and Professor |
| Affiliation |
Y.M.T. Ayurvedic Medical College and Hospital |
| Address |
Y.M.T. Ayurvedic Medical College and Hospital, Shalakya Tantra Department, Ground Floor, Institutional Area, Sector-4, Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nutan Radaye |
| Designation |
HOD and Professor |
| Affiliation |
Y.M.T. Ayurvedic Medical College and Hospital |
| Address |
Y.M.T. Ayurvedic Medical College and Hospital, Shalakya Tantra Department, Ground Floor, Institutional Area, Sector-4, Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9820512695 |
| Fax |
|
| Email |
nutan.radaye.nr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Y.M.T. Ayurvedic Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Chaitali Kulkarni |
| Address |
Y.M.T. Ayurvedic Medical College and Hospital, Institutional area, sector-4, Kharghar, Navi Mumbai- 410210 |
| Type of Sponsor |
Other [Self] |
|
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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 Chaitali Kulkarni |
Y.M.T. Ayurvedic Medical College and Hospital |
Shalakya Tantra Department, Ground Floor, Institutional Area, Sector-4, Kharghar, Navi Mumbai-410210
Raigarh
MAHARASHTRA |
9757398266
ckkulkarni512@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
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:H409||Unspecified glaucoma. Ayurveda Condition: ADHIMANTHAH, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Anti-glaucomatous eye-drops |
24 eyes with symptoms of Adhimantha with reference to Glaucoma will be selected randomly and treated with topical anti-glaucomatous eye-drops for a period of 18 days. |
| Intervention |
Viddhakarma |
24 eyes with symptoms of Adhimantha with reference to Glaucoma will be selected randomly and treated with Viddhakarma as an adjuvant therapy, on every alternate day for a duration of 18 days (10 sessions), along with topical anti-glaucomatous eye-drops. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
• Symptoms and signs of Adhimantha and Glaucoma like:
1. Netram nirmathyate vedana(churning-like pain in eyes)
2. Ardhashiraso vedana (half-sided headache)
3. Shankha Danta Kapoleshu Kapale Ruja (pain in temporal region, teeth, cheek, forehead).
4. Intraocular pressure (IOP) greater than 20.6 mmHg.
• Age group of 18-80 years. |
|
| ExclusionCriteria |
| Details |
1. Below 18 years and above 80 years of age.
2. Congenital glaucoma.
3. Hatadhimantha (Absolute Glaucoma).
4. Retinopathy due to any systemic disease.
5. Any other ocular diseases related to the Central nervous system.
6.Pregnancy and lactation. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
|
|
Blinding/Masking
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Ocular pain (VAS scale), Visual Acuity (LogMAR chart), Intraocular pressure (Schiotz tonometer) |
follow up on 0, 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 33rd, 48th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Optic cup-disc ratio, Neuro-retinal rim-disc ratio |
follow up on 0, 2nd, 4th, 6th, 8th, 10th, 12th, 14th, 16th, 18th, 33rd, 48th day |
|
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Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2021 |
| 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" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
NIL |
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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 STUDY OF EFFECTIVENESS OF VIDDHAKARMA + ANTI-GLAUCOMATOUS EYE-DROPS VERSUS ANTI-GLAUCOMATOUS EYE-DROPS ALONE IN ADHIMANTHA WITH REFERENCE TO GLAUCOMA.
NULL HYPOTHESIS: Viddhakarma + anti-glaucomatous eye-drops is equally effective as the anti-glaucomatous eye-drops alone on pain, IOP and visual acuity in Adhimantha w.r.t. Glaucoma. ALTERNATE HYPOTHESIS:
Viddhakarma + anti-glaucomatous eye-drops is more effective than anti-glaucomatous eye-drops alone on pain, IOP and visual acuity in Adhimantha w.r.t. Glaucoma. The study will be conducted in a single centre and will include 48 eyes with symptoms of Adhimantha and Glaucoma. 24 eyes will be treated with Viddhakarma as an adjuvant therapy for 18 days (alternate days-10 sessions) along with anti-glaucomatous eye-drops and 24 eyes will be treated with anti-glaucomatous eye-drops alone for 18 days.
ASSESSMENT CRITERIA:
Subjective criteria: Symptoms like: Netram nirmathyate vedana (churning-like pain in
eyes) Ardhashiraso vedana (half-sided headache) Shankha Danta Kapoleshu Kapale
Ruja (pain in temporal region, teeth,
cheek, forehead) Ocular pain: Visual Analogue Scale (VAS)
Objective Criteria: Visual Acuity Intraocular pressure Optic cup-disc ratio Neuroretinal rim-disc ratio
|