| CTRI Number |
CTRI/2020/01/022966 [Registered on: 27/01/2020] Trial Registered Prospectively |
| Last Modified On: |
17/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of samasharkara churna and kankayan vati in piles |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Samasharkara Churna with Kankayan Vati in the management of Arsha with special reference 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 |
Shruti Sandesh Shukla |
| Designation |
Pg scholar |
| Affiliation |
Ayurved seva sangh,Ayurved mahavidyalaya,nashik |
| Address |
Ayurved seva sangh,OPD NO 6,Shalyatantra OPD,Ayurved mahavidyalaya,,ganeshwadi
Panchvati,Nashik
Ayurved seva sangh,OPD NO 6,Shalyatantra OPD,Ayurved mahavidyalaya,,ganeshwadi
Panchvati,Nashik
Nashik
MAHARASHTRA
422009
India |
| Phone |
9021785801 |
| Fax |
|
| Email |
me.shrutishukla90@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinay R Sonambekar |
| Designation |
Professor & HOD Shalya Dept |
| Affiliation |
Ayurved seva sangh,Ayurved mahavidyalaya,nashik |
| Address |
Ayurved seva sangh,OPD NO 6,Shalyatantra OPD,Ayurved mahavidyalaya,,ganeshwadi
Panchvati,Nashik
Ayurved seva sangh,OPD NO 6,Shalyatantra OPD,Ayurved mahavidyalaya,,ganeshwadi
Panchvati,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinay R Sonambekar |
| Designation |
Professor & HOD Shalya Dept |
| Affiliation |
Ayurved seva sangh,Ayurved mahavidyalaya,nashik |
| Address |
Ayurved seva sangh,OPD NO 6,Shalyatantra Department,Ayurved mahavidyalaya,,ganeshwadi
Panchvati,Nashik
Ayurved seva sangh,OPD NO 6,Shalyatantra OPD,Ayurved mahavidyalaya,,ganeshwadi
Panchvati,Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822624890 |
| Fax |
|
| Email |
sonambekar.chinmay@gmail.com |
|
|
Source of Monetary or Material Support
|
| ASS Ayurved mahavidyalaya ,Arogyashala Rugnalaya, Ganeshwadi,Panchvati, Nashik |
|
|
Primary Sponsor
|
| Name |
Dr Shruti shukla |
| Address |
1 Gurukrupa Rowhouse
lane no 2 Behind Nirankari Bhavan
Govind Nagar
nashik |
| Type of Sponsor |
Other [Individual] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Ayurved Sevasanghs Ayurved Mahavidyalaya Ganeshwadi Nashik |
Ayurved Seva Sangh,Ayurved Mahavidyalaya,Panchavati Nashik |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shruti Sandesh Shukla |
Arogyashala Rugnalaya |
Ayurved seva sangh,Ayurved mahavidyalaya,nashik
Nashik
MAHARASHTRA |
9021785801
me.shrutishukla90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
kankayan wati |
2 tablets of 250mg bid with lukewarm water for 30 days |
| Intervention |
samsharkara churna |
2gm Bid with normal lukewarm water before meal for 30 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients diagnosed with Internal Haemorrhoids of I & II degree
2) Patients having following clinical features of Arsha
:
a) Agnimandya
b) Malavshtambha
c) Gudashula
d) SaraktaMalapravrutti
e) Gudakandu
3) Patients willing to participate with informed written consent. |
|
| ExclusionCriteria |
| Details |
Patients below age 20 years & above the age of 70 years
2) Patients with any major illness such as CA Large intestine, anal canal and
rectum, Rectal Polyps, Fistula in ano, Ulcerative colitis.
3) Pregnant women and lactating mothers.
9
4) Known cases of Diabetes mellitus as the trial drug is sugar based.
5) Severe anaemic patient
6) Patients with Bleeding Disorders, Crohn’s Disease, Liver cirrhosis, portal
hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in Sign n Symptoms of the condition like Agnimandya,Gud kandu,Malavshtambh,Gudshoola,Gudgat Raktastrava |
1 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Prevention of Occurrence of thrombosed piles,anorexia and Anaemia |
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
31/01/2020 |
| 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="1"
Months="0"
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)?
|
|
Brief Summary
|
This study is a comparative Clinical Evaluation of Samasharkara Churna with Kankayan Vati in the management of Arsha with special reference to Haemorrhoids in 100 patients with internal hemorrhoidsof 1 & 2nd degree, in aarogyshala rugnalaya ,ganeshwadi, panchvati,nashik. The objective of this study is to observe reduction in symtoms and demolition of pathophysiology of hemorrhoids for a month. |