| CTRI Number |
CTRI/2019/01/016973 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
07/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECT OF YOGA PRACTICES IN NON BLEEDING PROLAPSED HAEMORRHOIDS |
|
Scientific Title of Study
|
A CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFECT OF YOGA PRACTICE IN NON - BLEEDING PROLAPSING HAEMORRHOIDS(SHUSHKA ARSHA) |
| Trial Acronym |
YOGA,HAEMORRHOIDS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPoonam |
| Designation |
M.D. Scholar, Department of Swasthavritta and Yoga |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Dept. of Swasthavritta and Yoga,National Institute of Ayurveda, Near Jorawar Singh Gate,Amer Road Jaipur .
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9416703047 |
| Fax |
|
| Email |
dr.poonamyadav13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok Kumar |
| Designation |
Assistant Professor,Dept. of Shalya Tantra |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Dept. of Swasthavritta and Yoga,National Institute of Ayurveda, Near Jorawar Singh Gate,Amer Road Jaipur .
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9649180572 |
| Fax |
|
| Email |
ashok_hp1976@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kashinath Samagandi |
| Designation |
Assistant Professor,Dept. of Swasthavritta and Yoga |
| Affiliation |
National Institute of Ayurveda, Jaipur |
| Address |
Dept. of Swasthavritta and Yoga,National Institute of Ayurveda, Near Jorawar Singh Gate,Amer Road Jaipur .
Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
7877444353 |
| Fax |
|
| Email |
kashisri@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Ayurveda Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda Jaipur |
| Address |
Near Jorawar Singh Gate Amer Road Jaipur 302002 |
| 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 |
| DrPoonam |
National Institute of Ayurveda |
Room no 32, guda roga chikitsa, yoga unit , madhav vilas jorawer singh gate.
Jaipur
RAJASTHAN |
9416703047
dr.poonamyadav13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee National Institute Of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To treat non-bleeding haemorrhoids by given standard Ayurvedic medical regimen. |
To treat non-bleeding haemorrhoids by given standard Ayurvedic medical regimen.It include(Kasisadi tail 10 mlB.D.) and (Arshoghani vati 2-2 TDS) |
| Comparator Agent |
To treat non-bleeding haemorrhoids by given yoga practices. |
3 groups of yoga practices will be selected from
classical and contemporary literature which works on local muscles, status of agni and
constipation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group of 18 – 80 years
of either sex will be included.
2.Patients with 2 nd ,3 rd degree of non-
bleeding haemorrhoids. |
|
| ExclusionCriteria |
| Details |
ï‚·1.Piles with complications.
ï‚·2.Piles in pregnancy.
ï‚·3.Patients with fourth degree piles.
ï‚·4.Diagnosed patients suffering with any other
systemic diseases e.g. cardiac problems,
diabetes mellitus, hypertension, tuberculosis
etc. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Yoga practices may help to treat the prolapsing non-bleeding haemorrhoids, treat constipation. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mulabandh help in improving the sphincter tone of anal canal, yoga maintaint digestive health and improve the quality of life |
3 months after first patient registered. |
|
|
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 |
|
Date of First Enrollment (India)
|
09/01/2019 |
| 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
|
present study is planned to evaluate the effect on yoga practices on shushka Arsha mainly we select yoga modules which act on local muscles, constipation and jatharagni enhancer. which results to treat Arsha . And to rule out the role of modern life style in causation of Arsha |