| CTRI Number |
CTRI/2022/10/046507 [Registered on: 14/10/2022] Trial Registered Prospectively |
| Last Modified On: |
12/10/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical study of application of Kutaja Kshara in the management of Abhyantar Arsha w.s.r. to Internal Haemorrhoids |
|
Scientific Title of Study
|
“CLINICAL STUDY OF APPLICATION OF KUTAJA KSHARA IN THE
MANAGEMENT OF ABHYANTAR ARSHA W.S.R. TO INTERNAL
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 AKSHAY SAYRAM TUPE |
| Designation |
PG Scholar |
| Affiliation |
Government Ayurved College and Hospital, Vazirabad, Nanded |
| Address |
Dept of Shalyatantra
Government Ayurved College, Vazirabad,Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
9850897782 |
| Fax |
|
| Email |
ak.tupe1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V P Ukhalkar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College and Hospital, Vazirabad, Nanded |
| Address |
Dept of Shalyatantra
Government Ayurved College, Vazirabad,Nanded
Nanded
MAHARASHTRA
431601
India |
| Phone |
7755921987 |
| Fax |
|
| Email |
ukhalkarvp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V P Ukhalkar |
| Designation |
Associate Professor |
| Affiliation |
Government Ayurved College and Hospital, Vazirabad, Nanded |
| Address |
Dept of Shalyatantra
Government Ayurved College, Vazirabad,Nanded
MAHARASHTRA
431601
India |
| Phone |
7755921987 |
| Fax |
|
| Email |
ukhalkarvp@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurved College Vazirabad Nanded |
|
|
Primary Sponsor
|
| Name |
Dr Akshay Sayram Tupe |
| Address |
Dept of Shalyatantra Government Ayurved College and Hospital, Vazirabad, Nanded |
| 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 AKSHAY SAYRAM TUPE |
Government Ayurved Hospital Nanded |
Department of Shalyatantra
Hospital building
OPD No. 6 & 7
IPD Ward No. 51 & 63
Nanded
MAHARASHTRA |
9850897782
ak.tupe1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Sutrasthan adhyay 11 , Procedure details: Once a week for 3 consecutive weeks
It takes 15 mins for procedure )
(1) Medicine Name: Kutaja Kshara , Reference: Sushrut Sutrasthan adhyay 11 , Route: Topical, Dosage Form: Kshara, Dose: 0.50(g), Frequency: od, Duration: 3 Weeks | | 2 | Intervention Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: Sushrut Sutrasthan adhyay 11 , Procedure details: Once a week for 3 consecutive weeks
It takes 15 mins for procedure )
(1) Medicine Name: Kutaja Kshara , Reference: Sushrut Sutrasthan adhyay 11 , Route: Topical, Dosage Form: Kshara, Dose: 0.50(g), Frequency: od, Duration: 3 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with 1st and 2nd degree internal haemorrhoids |
|
| ExclusionCriteria |
| Details |
Haemorrhoids caused by other diseases
1. CA rectum
2. Pregnancy
3. Haemorrhoids with pelvirectal, ischiorectal abscess
4. Patient suffering from any systemic disease e.g. uncontrolled HTN, DM, TB, HIV Positive etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased P/R bleeding |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decreased P/R bleeding
Stool softness
Decreased Pruritus
Decreased degree of haemorrhoids |
28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/10/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is randomised, single blind, prospective, controlled clinical study of local application of Kutaja Kshara on 0th, 7th and 14th day with follow up on 0th,7th,14th and 28th day with sitz bath with luke warm water BID and Triphala churna 3gm orally HS in the management of Abhyantar Arsha W.S.R. to 2nd degree Internal Haemorrhoids. This study is conducted as PG course at single center. The primary outcome is to study the efficacy of local application of Kutaja Kshara in the management of Abhyantar Arsha W.S.R. to 2nd degree Internal Haemorrhoids. |