| CTRI Number |
CTRI/2024/07/070819 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [KSHARALEPA APPLICATION] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparative study to evaluate the effectiveness of á¹ igru tÄ«ká¹£na pratisÄranÄ«ya Ká¹£Ära against ApÄmÄrga tÄ«ká¹£na pratisÄranÄ«ya Ká¹£Ära in the management of second degree Haemorrhoids. |
|
Scientific Title of Study
|
A Randomized comparative clinical trial to evaluate the effectiveness of á¹ igru tÄ«ká¹£na pratisÄranÄ«ya Ká¹£Ära against ApÄmÄrga tÄ«ká¹£na pratisÄranÄ«ya Ká¹£Ära in the management of second degree Haemorrhoids |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr AMRUTHA K |
| Designation |
PG SCHOLAR |
| Affiliation |
VPSV Ayurveda college,kottakkal |
| Address |
Department of shalyatantra VPSV Ayurveda college kottakkal,malappuram,KERALA,676501,INDIA
Malappuram
KERALA
676502
India |
| Phone |
9995251960 |
| Fax |
|
| Email |
amruthapradeep036@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr sunitha P V |
| Designation |
PROFESSOR |
| Affiliation |
VPSV Ayurveda college,kottakkal |
| Address |
Department of shalyatantra VPSV Ayurveda college kottakkal,malappuram,KERALA,676501,INDIA
Malappuram
KERALA
676502
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr sunitha P V |
| Designation |
PROFESSOR |
| Affiliation |
VPSV Ayurveda college,kottakkal |
| Address |
Department of shalyatantra VPSV Ayurveda college kottakkal,malappuram,KERALA,676501,INDIA
Malappuram
KERALA
676502
India |
| Phone |
9447991388 |
| Fax |
|
| Email |
drsunitapv@gmail.com |
|
|
Source of Monetary or Material Support
|
| VPSV Ayurveda College Hospital Kottakkal,Malappuram district,Kerala,pincode 676501,India. |
|
|
Primary Sponsor
|
| Name |
VPSV Ayurveda college |
| Address |
VPSV Ayurveda college kottakkal,malappuram,KERALA,676501,INDIA |
| Type of Sponsor |
Other [aided 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 AMRUTHA K |
VPSV AYURVEDA COLLEGE HOSPITAL |
Room number 101 OPD Department of Shalyatantra, VPSV Ayurveda college, Hospital,Kottakkal,Malappuram District,Kerala,Pincode 676501.
Malappuram
KERALA |
9995251960
amruthapradeep036@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee(IEC) Vaidyaratnam P S Varrier Ayurveda CollegeKottakkal |
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 | Intervention Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: susruta samhita, Procedure details: PRE OPERATIVE PROCEDURES
Informed consent will be taken from the participant. Prior to procedure the participant will be advised to remain nil orally for at least 4 hours. The perianal part will be shaved & prepared. Soap water enema will be given 2 hours before the procedure.
OPERATIVE PROCEDURES
The patient will be made to lie in lithotomy position. The anal and perianal area will be cleaned with antiseptic solution. Then the slit proctoscope will be introduced into the anal canal to detect the exact position of pile mass. Then the pile mass will be cleaned with cotton swab and surrounding area will be covered with cotton to avoid injury. Then ṡigru Ká¹£Ära will be applied for trial group over the haemorrhoidal mass with the help of salÄka and retained for 100 matra or till the pile mass turn to purple black colour (pakva jambu phala varna). After this procedure the anal canal will be washed with
sterile tamarind water and wiped. This will help to neutralize PH and to remove all the remaining ká¹£Ära. Then ghee prepared with Yaá¹£ti Madhu will be smeared over the area and proctoscope will be removed.Thereafter the anal canal will be packed with gauze pads and the patient will be shifted to post operative ward for observation.
POST OPERATIVE
Sitz bath with luke warm water for two weeks 30 minutes morning and evening.
TREATMENT PERIOD – Single day
)
(1) Medicine Name: shigru kshara, Reference: raja nighantu, Route: Rectal, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 1 Days | | 2 | Comparator Arm | Procedure | - | kShArakarma, कà¥à¤·à¤¾à¤°à¤•à¤°à¥à¤® | (Procedure Reference: susruta samhita, Procedure details: PRE OPERATIVE PROCEDURES
Informed consent will be taken from the participant. Prior to procedure the participant will be advised to remain nil orally for at least 4 hours. The perianal part will be shaved & prepared. Soap water enema will be given 2 hours before the procedure.
OPERATIVE PROCEDURES
The patient will be made to lie in lithotomy position. The anal and perianal area will be cleaned with antiseptic solution. Then the slit proctoscope will be introduced into the anal canal to detect the exact position of pile mass. Then the pile mass will be cleaned with cotton swab and surrounding area will be covered with cotton to avoid injury.ApÄmÄrga Ká¹£Ära will be applied for control group over the haemorrhoidal mass with the help of salÄka and retained for 100 matra or till the pile mass turn to purple black colour (pakva jambu phala varna). After this procedure the anal canal will be washed with
sterile tamarind water and wiped. This will help to neutralize PH and to remove all the remaining ká¹£Ära. Then ghee prepared with Yaá¹£ti Madhu will be smeared over the area and proctoscope will be removed.Thereafter the anal canal will be packed with gauze pads and the patient will be shifted to post operative ward for observation.
POST OPERATIVE
Sitz bath with luke warm water for two weeks 30 minutes morning and evening.
TREATMENT PERIOD – Single day
)
(1) Medicine Name: apamarga kshara, Reference: susruta samhita, Route: Rectal, Dosage Form: Kshara, Dose: 1(g), Frequency: od, Duration: 1 Days |
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants with second degree Haemorrhoids.
Age group of 21-60 years, irrespective of gender |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Subjective assessment based on clinical signs and symptoms- Assessment of feeling of
protrusion of mass during defecation Objective assessment based on Proctoscopy
Photos of pile mass before and after the intervention will be included.
Assessment of subjective and objective parameters |
As per the subjective and objective criteria,the assessment will be done on the day of kshara karma,and on 3rd day,5th day,7th day andfollowup will be done on 14 th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Subjective assessment based on clinical signs and symptoms- Assessment of feeling of
protrusion of mass during defecation Objective assessment based on Proctoscopy
Photos of pile mass before and after the intervention will be included.
Assessment of subjective and objective parameters |
before the study, 1st ,3rd,
5th,7thday.
Follow up will be done on 14th day
|
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="38" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2024 |
| Date of Study Completion (India) |
01/06/2025 |
| Date of First Enrollment (Global) |
01/08/2024 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A randomised comparative clinical trial is planned in second degree haemorrhoids to compare shigru pratisaraneeya kshara and apamarga pratisaraneeya kshara.In second degree haemorrhoids they come out only through defecation and return by itself.In ayurveda classics detailed description regarding haemorrhoids are given which are known as arsas.kshara karma procedure is the choice when haemorrhoids are mrudu,prasrita,avagada,and uchritha.The phytochemistry and pharmacological effect of shigru are studied and it is found that it posses potential pharmacological actions including antiinflammatory,antimicrobial and wound healing property.
|