| CTRI Number |
CTRI/2021/04/032923 [Registered on: 19/04/2021] Trial Registered Prospectively |
| Last Modified On: |
17/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"A COMPARATIVE STUDY ON EFFICACY OF APAMARGA PRATISARNIYE KSHARA ( EXTERNAL APPLICATION OF MEDICATED ALKALINE POWDER) AND ORAL INTAKE OF ARSHOGHANI VATI (MEDICINE FOR PILES ) IN INTERNAL HAEMORRHOIDS (PILES) |
|
Scientific Title of Study
|
“A COMPARATIVE STUDY ON EFFICACY OF APAMARGA PRATISARNIYA KSHARA AND ORAL INTAKE OF ARSHOGHANI VATI IN INTERNAL HAEMORRHOIDS†|
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr poonamarya |
| Designation |
Pg scholar |
| Affiliation |
Shri krishna government ayurvedic College and hospital , kurukshetra |
| Address |
Room no. - 103 pg department of Shalya tantra, shrikrishna government ayurvedic College and hospital sec -8 , umri road , kurukshetra
Room no. - 103 pg department of Shalya tantra, shrikrishna government ayurvedic College and hospital sec -8 , umri road , kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9588127836 |
| Fax |
|
| Email |
drpoonamarya95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shriniwas Gujjarwar |
| Designation |
Professor |
| Affiliation |
Shri krishna government ayurvedic College and hospital , kurukshetra |
| Address |
Room no. - 103 pg department of Shalya tantra, shrikrishna government ayurvedic College and hospital sec -8 , umri road , kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9729092181 |
| Fax |
|
| Email |
ayurvedgoa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr poonamarya |
| Designation |
Pg scholar |
| Affiliation |
Shri krishna government ayurvedic College and hospital , kurukshetra |
| Address |
Room no. - 103 pg department of Shalya tantra, shrikrishna government ayurvedic College and hospital sec -8 , umri road , kurukshetra
Room no. - 103 pg department of Shalya tantra, shrikrishna government ayurvedic College and hospital sec -8 , umri road , kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9588127836 |
| Fax |
|
| Email |
drpoonamarya95@gmail.com |
|
|
Source of Monetary or Material Support
|
| shri krishna government ayurvedic college kurukshetra |
|
|
Primary Sponsor
|
| Name |
dr poonam arya |
| Address |
Room no. - 103 pg department of Shalya tantra, shrikrishna government ayurvedic College and hospital sec -8 , umri road , kurukshetra |
| Type of Sponsor |
Other [Self] |
|
|
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 Shriniwas Gujjarwar |
Shri krishna government ayurvedic College and hospital, kurukshetra |
Room no. - 103 pg department of Shalya tantra, shrikrishna government ayurvedic College and hospital sec -8 , umri road , kurukshetra
Kurukshetra
HARYANA |
9729092181
ayurvedgoa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
local application of apamarga pratisarniye kshara |
Written informed consent will be taken. The apamarga kshar will be applied on internal haemorrhoids with the help of probe. After count of one minute , kshar will be cleansed with lemon juice . |
| Comparator Agent |
Oral intake of Arshoghani vati. |
arshoghani vati will be taken 500mg/ 8 hourly with lukewarm water for 15 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ï‚· Age group from 20 to 60 years.
ï‚· The patient who ready to give consent for treatment.
ï‚· Internal haemorrhoids with 1st degree, 2nd& 3rd degree will be considered for clinical
trial. |
|
| ExclusionCriteria |
| Details |
Age below 20 years and above 60years
ï‚· Pregnancy
ï‚· 4
th degree strangulated , thrombosed & external haemorrhoids.
ï‚· Uncontrolled diabetes, HIV positive cases, tuberculosis, ulcerative colitis,
Hypertension, HBs Ag positive cases, leprosy, anemia, IBS.
ï‚· Haemorrhoid associate with fissure in Ano and Fistula in Ano. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in size of pile mass. |
Every third day upto one month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in bleeding , pruritus ani & mucus discharge. |
Every third day upto one month. |
|
|
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)
|
22/04/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
No |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Haemorrhoids becomes large & cause problem to general population. Ratio of Haemorrhoids in men & women are 2:1. Different treatment modalities are available like expectant medical therapy, Injectiontreatment, Rubber band ligation, Cryosurgery, Infrared coagulation &Operative treatment. However the risk of reoccurrence or developing an infection of wound after the operation becomes high. As per Sushruta Samhita for folds of treatment namely Bheshaja, Kshara, Agni & Shastra Karma, along. Among of these Kshara Karma in particular , is cost effective , needs minimal hospitalization & has least adverse effects. |