| CTRI Number |
CTRI/2020/07/026541 [Registered on: 14/07/2020] Trial Registered Prospectively |
| Last Modified On: |
11/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Role of ARSHAKALP VATI in piles |
|
Scientific Title of Study
|
A Clinical Study TO Evaluate the Efficacy of ARSHAKALP VATI in GUDA ARSHA W.S.R. to HAEMORRHOIDS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay kumar gupta |
| Designation |
Professor |
| Affiliation |
Rishikul ayurvedic collage and hospital haridwar |
| Address |
Rishikul campus,Shalya Tantra Departement,UAU, haridwar Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL
Rishikul campus,Shalya Tantra Departement,UAU, haridwar Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay kumar gupta |
| Designation |
Professor |
| Affiliation |
Rishikul ayurvedic collage and hospital haridwar |
| Address |
Rishikul campus,Shalya Tantra Department,UAU, haridwar Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL
Rishikul campus,Shalya Tantra Department,UAU, haridwar Hardwar UTTARANCHAL
Hardwar
UTTARANCHAL
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9412856414 |
| Fax |
|
| Email |
akg1409@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay kumar singh |
| Designation |
pg scholar |
| Affiliation |
Rishikul ayurvedic collage and hospital haridwar |
| Address |
Rishikul campus ,Shalya Tantra Department, U.A.U, haridwar
Hardwar
UTTARANCHAL
249401
India
Rishikul campus ,Shalya Tantra Department, U.A.U, haridwar
Hardwar
UTTARANCHAL
249401
India
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8960616504 |
| Fax |
|
| Email |
sanjayyazik786@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no.7 and IPD no 7 of shalya tantra department rishikul campus |
|
|
Primary Sponsor
|
| Name |
Uttrakhand Ayurved University |
| Address |
Uttrakhand ayurved university ,railway road, harrawala,dehradun |
| Type of Sponsor |
Government medical college |
|
|
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 AKGupta |
Rishikul ayurvedic collage and hospital |
OPD no7 and IPD no7 Shalya Tantra Department
Hardwar
UTTARANCHAL |
9412856414
akg1409@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC,Uttrakhand ayurved university,Rishikul CAMPUS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K641||Second degree hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ARSHAKALP VATI |
ARSHAKALP VATI- 2 tab. Twice a day before meal with lukewarm water.3 month duration with 3 months followup |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The patients having complaints of I and II-degree hemorrhoids will be taken for the study after screening.
External pile mass of small in size
|
|
| ExclusionCriteria |
| Details |
Patients below the age of 18 years
III & IV-degree internal pile
Pregnancy
Congenital deformity
Carcinoma
Tuberculosis
Heart disease
Rectal prolapsed
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain,Constipation,Bleeding per rectum, Prolapse pile mass per rectum (grade0,1,2,3) |
once in a month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ARSHAKALP VATI- 2 tab. Twice a day before meal with lukewarm water |
after 3 months |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/07/2020 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Haemorrhoid is one of the commonest disease occurring
in the ano- rectal region and can affect anyone, anywhere, anytime. Its
incidence increases with advancing age, at least 50% of people over the age of
50 years have some degree of haemorrhoidal symptoms due to hereditary,
anatomical deformities, diet, and life style etc., from the time immemorial.
Haemorrhoid can be compared with the Arsha at Ayurvedic parlance.
Arsha/Haemorrhoid is considered as one of the extremely
uncomfortable, painful and embarrassing problems that affect several people of
the world annually. Though the condition is not fatal but it is very
disconcerting and may make the person to lose interest in all activity.
Ayurveda, the science of life, is based on the
time-tested observations and medical experiences. It has immense potential to
evolve solution of many challenging and unresolved problems of the medical
world. Considering
Mandagni as the prime etiopathogenic factor a lot of oral medications
have been described in ayurvedic classics and present study is planned
to evaluate the efficacy of such medicine without any side effects and
complications
|