| CTRI Number |
CTRI/2020/08/027123 [Registered on: 13/08/2020] Trial Registered Prospectively |
| Last Modified On: |
08/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative clinical study of four different variety of Teekshana Apamarga Pratisaraneeya Kshara in the management of Abhyantara Arsha with special reference to internal Haemorrhoids |
|
Scientific Title of Study
|
A comparative clinical study of Chitraka, Karanja, Vacha and Danti Prativaapit Teekshana Apamarga Pratisaraneeya Kshara in the management of Abhyantara Arsha (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 Richa Sharma |
| Designation |
Ph. D Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of Shalya Tantra National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8218692983 |
| Fax |
|
| Email |
richasharmaskd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr P Hemantha Kumar |
| Designation |
Professor and Head |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of Shalya Tantra National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414056362 |
| Fax |
|
| Email |
profphknia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Richa Sharma |
| Designation |
Ph. D Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur Rajasthan |
| Address |
Department of Shalya Tantra National Institute of Ayurveda Jaipur Rajasthan
Jaipur
RAJASTHAN
302002
India |
| Phone |
8218692983 |
| Fax |
|
| Email |
richasharmaskd@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Madhav vilas palace, Jorawar singh gate,Amer road, Jaipur, Rajasthan. INDIA, PIN-302002 |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda,Madhav vilas palace, near Jorawar singh gate, Amer road, Jaipur, Rajasthan, INDIA, PIN-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 |
| Dr Richa Sharma |
National Institute of Ayurveda |
OPD no.28 and IPD, Department Of Shalya Tantra Madhav vilas palace, Jorawar singh gate,Amer road, Jaipur, Rajasthan. INDIA, PIN-302002
Jaipur
RAJASTHAN |
8218692983
richasharmaskd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC National Institute of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Chitraka, Karanja, Vacha and Danti Prativaapit Teekshana Apamarga Pratisaraneeya Kshara |
Chitraka or Karanja or Vacha or Danti Prativaapit Teekshana Apamarga Pratisaraneeya Kshara will be applied locally on each haemorrhoidal mass in dose between 250 mg -1.0 gm and its thickness between 0.5 -1.0 mm. After applying Kshara on internal haemorrhoids, wait for 1-2 minutes or until they acquire Pakva Jambuphala Sadrusha Varna.It will be applied once.
Then wash it with Nimbu Swarasa.Single sitting will be given.Assessment period will be 3 weeks( i.e on 1st post-operative day, 1st week, 2nd week and 3rd week of intervention) .Follow up will be done monthly once for 3 months( i.e.on 7th week, 11th week and 15th week of intervention)
|
| Intervention |
Teekshana Apamarga Pratisaraneeya Kshara |
Teekshana Apamarga Pratisaraneeya Kshara will be applied locally on each haemorrhoidal mass in dose between 250 mg -1.0 gm and its thickness between 0.5 -1.0 mm. After applying Kshara on internal haemorrhoids, wait for 1-2 minutes or until they acquire Pakva Jambuphala Sadrusha Varna.It will be applied once.
Then wash it with Nimbu Swarasa.Single sitting will be given.Assessment period will be 3 weeks( i.e on 1st post-operative day, 1st week, 2nd week and 3rd week of intervention) .Follow up will be done monthly once for 3 months( i.e.on 7th week, 11th week and 15th week of intervention)
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with the sign and symptoms of Arshas of Pittaja and Raktaja origin.
Arsha which are of Mridu, Prasrita, Avagadha (deep) and Uchchrita (projected).
First, second and third degree internal haemorrhoids.
|
|
| ExclusionCriteria |
| Details |
Patients with age less than 16 yrs and more than 70 yrs.
Patients with known systemic illness like uncontrolled Diabetes mellitus, Hypertension, malignancy etc.
HBsAg, HCV and Retrovirus positive patients.
Internal haemorrhoids due to secondary causes.
Fourth degree internal haemorrhoids.
External haemorrhoids.
Internal haemorrhoids with associated
anorectal diseases, pelvic pathology or
pregnancy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective criteria -Raktasrava (bleeding per rectum),Ruja (post operative pain),
Objective criteria- size of pile mass, colour of pile mass,sphincter tone
|
1 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction score,recovery time,time to return to work,length of hospital stay
|
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
13/08/2020 |
| 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="4"
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)?
Response - NO
|
|
Brief Summary
|
Ayurveda is well known for the treatment of Arsha with Pratisaraneeya Kshara Karma for yielding negligible rate of recurrence , cost effective, less pain, no bleeding, no infection , no anal incontinence and requiring minimal hospitalization during treatment. Earlier studies have been conducted on Chitraka Prativaapit Teekshana Apamarga Pratisaraneeya Kshara but no earlier study conducted to evaluate the efficacy of Karanaja Vacha, Danti Prativaapit Teekshana Apamara Pratisaraneeya Kshara for the treatment of haemorrhoids. In the view of above mentioned facts, A humble effort has been done in he form of this clinical study entitled" A comparative clinical study of Chitraka , Karanja, Vacha and Danti Prativaapit Teekshana Apamarga Pratisaraneeya Kshara in the management of Abhyantara Arsha ( Internal Haemorrrhoids) |