| CTRI Number |
CTRI/2021/12/038475 [Registered on: 07/12/2021] Trial Registered Prospectively |
| Last Modified On: |
04/12/2021 |
| 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
|
Ayurvedic management of simple allergic conjunctivitis |
|
Scientific Title of Study
|
Efficacy of shigru patra churna in the management of vataja abhishyanda w.s.r to simple allergic conjunctivitis-A randomized controlled clinical trial |
| Trial Acronym |
AMSAC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SANAMIKA GUPTA |
| Designation |
PG Scholar |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya |
| Address |
Department of PG Studies in Shalakya Tantra, KAHERs Shri BMK Ayurveda Mahavidyalaya, Shahapur, Belagavi
Belgaum
KARNATAKA
590003
India |
| Phone |
9315672949 |
| Fax |
|
| Email |
sanamikagupta1301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meghana B Patil |
| Designation |
Asst Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya |
| Address |
Asst Professor
Department of Shalakya Tantra KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9916871886 |
| Fax |
|
| Email |
megs816@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meghana B Patil |
| Designation |
Asst Professor |
| Affiliation |
KAHERs Shri BMK Ayurveda Mahavidyalaya |
| Address |
Asst Professor
Department of Shalakya Tantra KAHERs Shri BMK Ayurveda Mahavidyalaya Shahapur Belagavi
Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9916871886 |
| Fax |
|
| Email |
megs816@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE ACADEMY OF HIGHER EDUCATION AND RESEARCHES OWNED SHRI BM KANKANWADI AYURVEDA MAHAVIDYALAYA AND KLE AYURVEDA HOSPITAL AND RESEARCH CENTRE SHAHAPUR BELAGAVI |
|
|
Primary Sponsor
|
| Name |
SANAMIKA GUPTA |
| Address |
PG SCHOLAR DEPARTMENT OF SHALAKYA TANTRA KAHERS SHRI BM KANKANAWADI AYURVEDA MAHAVIDYALAYA SHAHAPUR BELAGAVI
KARNATAKA
|
| Type of Sponsor |
Other [SELF SPONSORED PG DISSERTATION WORK] |
|
|
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 |
| SANAMIKA GUPTA |
KAHERS SHRI BM KANKANAWADI AYURVEDA MAHAVIDYALAYA AND HOSPITAL SHAHAPUR BELAGAVI |
OPD NO 26 & 27,
Department of Shalakya Tantra
Belgaum
KARNATAKA |
9315672949
sanamikagupta1301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:H108||Other conjunctivitis. Ayurveda Condition: VATAJA ABHISHYANDA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shigru (Moringa oleifera ) , Reference: Bhava prakash, neta roga chikitsa, chaksushya 105-107, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: shigru patra churna orally in simple allergic conjunctivitis | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridrakhand, Reference: bhaishaja ratnavali udardha sheeta pitta kota chikitsa 13-17, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -lukewarm water), Additional Information: haridrakhanda orally in simple allergic conjunctivitis |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients presenting with signs and symptoms of Vataja Abhishyanda and fulfilling the
diagnostic criteria
2. Patients with age group of 18 - 60yrs
3. Patients of either sex |
|
| ExclusionCriteria |
| Details |
1. Patients suffering from vernal Kerato conjunctivitis, Atopic Kerato conjunctivitis, Giant papillary conjunctivitis.
2. Patients having complicated eye diseases, Trachoma, Chalazion, Stye, Pterygium, Dacryocystitis, Trichiasis, etc.
3. Patients suffering from Corneal Opacity, Ulcers.
4. Diagnosed cases of Glaucoma and any ophthalmic infective conditions will be excluded.
5. Patients with other systemic disorders like renal diseases, uncontrolled hyperglycemia and hyperlipidemia, cardiovascular diseases etc. will be excluded.
6. Extremely debilitated patients and in pregnant |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shigru patra churna if proved effective would help in treating vataja abhishyanda more efficiently. |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
16/12/2021 |
| 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" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
THE STUDY IS RANDOMIZED CONTROLLED CLINICAL STUDY TO EVALUATE EFFICAY OF SHIGRU PATRA CHURNA IN THE MANAGEMENT OF VATAJA ABHISYANDA AND TO COMPARE WITH HARIDRAKHANDA CHURANA FOR A PERIOD OF 15 DAYS. STUDY WILL BE CONDUCTED IN KAHERs SHRI B M KANKANWADI AYURVEDA MAHAVIDYALAYA AND RESEARCH CENTRE OWNED KLE AYURVEDA HOSPITAL SHAHAPUR BELAGAVI KARNATAKA INDIA. THE EXPECTED OUTCOME IS TO BRING DOWN THE SYMPTOMS NORMAL. |