| CTRI Number |
CTRI/2024/08/072967 [Registered on: 23/08/2024] Trial Registered Prospectively |
| Last Modified On: |
20/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic Management of Hemorrhoids |
|
Scientific Title of Study
|
An Open Labelled Clinical Study To Evaluate The Effect Of Chitraka Pratisaraneeya Teekshna Kshara In Abhyantara Arshas w.s.r. To Internal 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 K Anushree |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheswara college of ayurveda,kuthpady,udupi |
| Address |
Department of PG studies in Shalya Tantra Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Kuthpady Udupi Karnataka Udupi KARNATAKA 574118
Udupi
KARNATAKA
574118
India |
| Phone |
7204750369 |
| Fax |
|
| Email |
anushree2297@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth K |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara college of ayurveda,kuthpady,udupi |
| Address |
Department of PG studies in Shalya Tantra Sri Dharmasthala
Manjunatheshwara college of Ayurveda and Hospital Kuthpady Udupi
Karnataka
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9448857560 |
| Fax |
|
| Email |
drp235@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashanth K |
| Designation |
Associate Professor |
| Affiliation |
Sri Dharmasthala Manjunatheswara college of ayurveda,kuthpady,udupi |
| Address |
Department of PG studies in Shalya Tantra Sri Dharmasthala
Manjunatheshwara college of Ayurveda and Hospital Kuthpady Udupi
Karnataka
Udupi
KARNATAKA
574118
India
Udupi
KARNATAKA
574118
India |
| Phone |
9448857560 |
| Fax |
|
| Email |
drp235@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheswara Ayurveda Pharmacy Kuthpady Udupi
Karnataka 574118 |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheswara college of ayurveda |
| Address |
Sri Dharmasthala Manjunatheswara college of Ayurveda and
Hospital Kuthpady Udupi Karnataka 574118 |
| Type of Sponsor |
Private 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 K Anushree |
Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Kuthpady Udupi Karnataka 574118 |
OPD 5 Department of Shalyatantra Sri Dharmasthala Manjunatheswara college of Ayurveda and Hospital Kuthpady Udupi Karnataka 574118
Udupi
KARNATAKA |
7204750369
anushree2297@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sri Dharmasthala Manjunatheswara college of ayurveda and hospital udupi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: ARSAH, (2) ICD-10 Condition:K649||Unspecified 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: sushruta samhita sutrasthana, Procedure details: application of chitraka teekshna kshara in abhyantara arshas)
(1) Medicine Name: chitraka teekshna kshara, Reference: sushruta samhita sutrasthana 11 chapter, Route: Rectal, Dosage Form: Kshara, Dose: 1(mg), Frequency: od, Duration: 1 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kaishora guggulu, Reference: sharangadhara samhita madhyama khanda 7verse , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 750(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(2) Medicine Name: Gandhaka rasayana, Reference: Rasatarangini 8verse 81 to 86, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 750(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -(3) Medicine Name: swadishta virechana churna, Reference: rasatantra sara, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients between the age group of 18-70 years.
Diagnosed case of Internal Haemorrhoids. |
|
| ExclusionCriteria |
| Details |
External Haemorrhoids, Intero External Haemorroids.
Haemorrhoids with complications like thrombosed, infected, strangulated, prolapsed.
Haemorrhoids associated with malignancy, pregnancy, fistula-in-ano, ulcerative colitis, proctitis, abscess,
uncontrolled diabetes, chronic liver disease, HBsAg, HIV, tuberculosis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the effect of Chitraka Pratisaraneeya Teekshna Kshara in Abhyantara Arshas by observing changes in state and size of pile mass |
State of pile mass
Size of pile mass
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Observing changes in VAS scale, state and size of hemorrhoids |
45days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
31/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Hemorrhoids is abnormal sliding of anal cushions due to straining, constipation, low fibre diet and hereditary. Similarly Arshas one among ashtamahagada is caused due to sahajatani, virudhahara sevana, vegadharana which lead to derangement of doshas affecting gudavalli. Here Chitraka Pratisaraneeya Teekshna Kshara will be used in Abhyantara Arshas. 30 patients will be selected who will fulfill the inclusion criteria for study for study and patient will be assessed before and after the treatment. |