| CTRI Number |
CTRI/2022/10/046206 [Registered on: 06/10/2022] Trial Registered Prospectively |
| Last Modified On: |
05/10/2022 |
| 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
|
To see how krushna til kalka works in bleeding piles |
|
Scientific Title of Study
|
Randomized open controlled clinical study of Krushna til kalka in Raktaarsha w.s.r to Bleeding Piles. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Dhengale |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College, P.G. Training & Research Center, Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,Shalyatantra department Second floor,Kodoli dist kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9767189206 |
| Fax |
|
| Email |
dr.ravidhengale@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ardra Thorat |
| Designation |
Asso Professor |
| Affiliation |
Yashwant Ayurvedic College, P.G. Training & Research Center, Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,Shalyatantra department Second floor,Kodoli dist kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9970223088 |
| Fax |
|
| Email |
drardrathorat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ardra Thorat |
| Designation |
Asso Professor |
| Affiliation |
Yashwant Ayurvedic College, P.G. Training & Research Center, Kodoli |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,Shalyatantra department Second floor,Kodoli dist kolhapur.
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9970223088 |
| Fax |
|
| Email |
drardrathorat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic Medical College PGT and RC kodoli,
shalyatantra department opd no 4, kodoli dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
|
|
Primary Sponsor
|
| Name |
Dr Ravi Dhengale |
| Address |
Yashwant Ayurvedic Medical College PGT and RC kodoli,
shalyatantra department opd no 4, kodoli dist kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| 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 Ravi Dhengale |
Yashwant Ayurvedic Medical College PGT and RC kodoli, dist kolhapur |
shalyatantra
department opd no 4,
kodoli dist kolhapur
Kolhapur
MAHARASHTRA |
9767189206
dr.ravidhengale@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
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. Ayurveda Condition: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Krushna Til Kalka, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Kalka/ Paste , Dose: 10(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: Goat Milk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tab Anocare, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: -no |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients Having Clinical Feature Of Raktarsha
Patients With Duration Of Complaints Less Than 6 Months
Patients With First & Second Degree Bleeding Piles |
|
| ExclusionCriteria |
| Details |
Patients With Third & Fourth Degree Bleeding Piles
Piles Associated With Perianal Abcess , Fissure , Fistula , Rectal Prolapse , K/C/O Ulcerative Colitis , CA Rectum , HIV , HbsAg, T.B , DM |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms like P/R Bleeding, Pain, Burning |
At 1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms like P/R Bleeding, Pain, Burning |
At 15 Days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/10/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Non 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 Based On
Randomized Open Controlled Clinical Study To Evaluate The
Efficacy Of Til Kalka Orally In Raktarsha W.S.R To Bleeding Piles .The observation would be drawn on he basis of symptoms after treatment given. |