| CTRI Number |
CTRI/2022/06/043357 [Registered on: 20/06/2022] Trial Registered Prospectively |
| Last Modified On: |
09/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of pratisarniya kshar and Laser procedure in Haemorrhoids |
|
Scientific Title of Study
|
A Comparative Study of Effect of Pratisaraniya Kshara And Laser Therapy 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 Singh |
| Designation |
PG Scholar /Junior resident doctor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi-221005
6/202 MIG AWAS VIKAS COLONY
yojana-3
Jhunsi-Prayagraj
UP-211019
Allahabad
UTTAR PRADESH
221005
India |
| Phone |
7607454299 |
| Fax |
|
| Email |
shrutisingh002@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shiv Ji Gupta |
| Designation |
Professor and Head |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415227419 |
| Fax |
|
| Email |
guptasjbhu@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Prof Shiv Ji Gupta |
| Designation |
Professor and Head |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Shalya Tantra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415227419 |
| Fax |
|
| Email |
guptasjbhu@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of Shalya Tantra
faculty of Ayurveda
Institute of medical sciences
Banaras Hindu university
varanasi-221005 |
|
|
Primary Sponsor
|
| Name |
Head Department of Shalya Tantra |
| Address |
Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi-221005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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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 Singh |
Sir Sundar Lal Hospital |
Ayurveda wing(indian medicine0
shalya OPD-14
NRC OPD
Banaras Hindu University
Varanasi
UTTAR PRADESH |
7607454299
shrutisingh002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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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:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | laser therapy | 10-12 effective pulses ,10W per 3 sec using a 980nm diode laser generator will be fired.
Maxium energy to be transferred to each pile mass will be 200-250 J
Follow up study of patients in each group will be done on 7th day,14th day,21st day and 30th day. | | 2 | Intervention Arm | Procedure | - | pratisAraNIya-kShAraH, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¥€à¤¯-कà¥à¤·à¤¾à¤°à¤ƒ | (Procedure Reference: Sushruta samhita chikitsa sthana 6, Procedure details: The patient will be kept in lithotomy position.
Perianal part will be painted and draped with a sterilized cut sheet.
Then a lubricated proctoscope will be introduced in anal canal.
The pile mass will be fixed at the suitable place into aperture.
After cleaning the pile mass with gauze piece, tikshna Apamarga kshara will be applied .
Applied kshara will be kept till the time taken to count 100 or till reddish or purpulish black colour (PakvaJambuPhala Varna) is obtained.
Then the ksha)
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient coming with complain of Arsha (Grade II and III haemorrhoids) i.e. bleeding per rectum, discharge and pruritus. |
|
| ExclusionCriteria |
| Details |
1. Grade I and Grade IV Haemorrhoids
2. CA rectum
3. Thrombosed pile mass
4. Uncontrolled Hypertension
5. Uncontrolled Diabetes mellitus
6. Hypertrophid anal papilla
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
. Bleeding per rectum
2. Decrease in size or grade of Haemorrhoids.
3. Post operative pain
4. Post operative discharge.
5.Colour of haemorrhoidal mass assessed just after operative procedure
and during follow up.
6. Frequency of stool.
7.Anal stenosis.
|
7th day
14th day
21st day
30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| complete relief in symptom i.e.BLEEDING per anum |
in 1 month |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
25/06/2022 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A total 64 number of patients, who are fulfilling the inclusion criteria,wiill be registered from OPD/IPD of Shalya Tantra Department, Faculty of Ayurveda-IMS BHU Varanasi. Patient will be registered irrespective of their age, sex, religion, occupation, education and socio-economic status. Present study will be carried out in 2 groups: Group A : 32 Patient will be treated by application of Apamarg Pratisarniya Kshara along with Ayurvedic therapy. Group B :32 Patients will be treated by laser therapy along with Ayurvedic therapy . Ayurvedic therapy common in both Groups-(Prescribed for 30 days) Arshoghani vati -500mg BD Chitrakadi vati-500mg BD Abhayarishta-20ml BD Ttriphla churna -6 gm H.S with lukewarm water Kasisadi Taila Basti (5ml P/R before defecation) Sitz bath Follow up study of patients in each group will be done on 7th day,14th day,21st day and 30th day.
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