| CTRI Number |
CTRI/2021/07/034567 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
29/06/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [curative] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
CLinical study on Arshas to evaluate the efficacy of Nyagrodhapatra lepa on Haemorrhoids. |
|
Scientific Title of Study
|
A comparative clinical study to evaluate the efficacy of Nyagrodhapatra lepa and Arshogna lepa in Arshas |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreya P |
| Designation |
PG Scholar MS Shalya Tantra |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of PG Studies in Shalya Tantra
Alvas Ayurveda Medical college and Hospital
Moodbidri
Dakshina kannada district
karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9074835993 |
| Fax |
|
| Email |
sreyap024@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunatha Bhat |
| Designation |
PG Dean HOD of Department of Shalya Tantraand Guide |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of PG Studies in Shalya Tantra
Alvas Ayurveda Medical college and Hospital
Moodbidri
Dakshina kannada district
karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9686751182 |
| Fax |
|
| Email |
dmbg2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreya P |
| Designation |
PG Scholar MS Shalya Tantra |
| Affiliation |
Alvas Ayurveda Medical college and Hospital |
| Address |
Department of PG Studies in Shalya Tantra
Alvas Ayurveda Medical college and Hospital
Moodbidri
Dakshina kannada district
karnataka
574227
Dakshina Kannada
KARNATAKA
574227
India |
| Phone |
9074835993 |
| Fax |
|
| Email |
sreyap024@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas Ayurveda Medical college and Hospital vidyagiri Moodbidri Dakshina kannada Karnataka 574227 |
|
|
Primary Sponsor
|
| Name |
Greeshma P |
| Address |
D/o Narayanan A
Oliyathadukkam (h)
Vattamthatta (p.o)
Muliyar (via)
Kasaragod
Pin 671542
|
| Type of Sponsor |
Other [] |
|
|
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 Sreya P |
Alvas Ayueveda Medical College and Hospital Moodbidri |
Shalya tantra Minor Ot Department of PG Studies in Shalya Tantra room no 5 second floor vidyagiri Moodbidri
Dakshina Kannada
KARNATAKA |
9074835993
sreyap024@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Arshogna lepa |
Arshogna lepa will be applied on each patient of arsha once in a day for 7 days |
| Intervention |
Nyagrodha patra lepa |
Nyagrodha patra lepa will be applied on each patient of arsha once in a day for 7 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of 2nd and 3rd degree haemorrhoids |
|
| ExclusionCriteria |
| Details |
1st and 4th degree haemorrhoids
Haemorrhoids that are thrombosed,strangulated and inflamed
Haemorrhoids with fissure in ano,fistula in ano,Rectal polyps,CA rectum,Rectal prolapse,Inflammatory bowel disease,proctitis,perianal and rectal abscess
patients having TB,DM,Hypertension,Coagulopathies,HIV,HBsAg positive
pregnant women |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Mass per anum
Bleeding per rectum
mucous discharge per anum
itching
constipation
pain |
7 days with assessment on 8th 15th 22nd and 29th day
Follow up on 45th and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/07/2021 |
| 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="15" |
|
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
|
It is a comparative clinical study to evaluate the efficacy of Nyagrodha patra lepa and Arshoghna lepa in Arshas for 7 days in 60 patients of Haemorrhoids will be conducted in Alvas Ayurveda Medical college and Hospital vidyagiri Moodbidri dakshina kannada Karnataka India Primary outcome measure will be relief from bleeding per anum Pain Constipation Mass per anum |