| CTRI Number |
CTRI/2024/09/073233 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Efficacy Of Jyotishmati Beeja Kalka Lepa In The Management Of Raktarsha With Special Reference To I And II Degree Internal Haemorrhoids |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study The Efficacy Of Jyotishmati Beeja Kalka Lepa In The Management Of Raktarsha With Special Reference To I And II Degree 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 Sweety Rushi Undirwade |
| Designation |
MS Scholar Shalyatantra(Ayurveda) |
| Affiliation |
LRP Ayurvedic Medical College And Hospital |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Sangli, Department of Shalyatantra unit 3 Room no 4 Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9404410554 |
| Fax |
|
| Email |
1822sweet@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramchandra Shedage |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Sangli, Department of Shalyatantra unit 3 Room no 4 Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Ramchandra Shedge |
| Designation |
Professor |
| Affiliation |
LRP Ayurvedic Medical College And Hospital |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Sangli, Department of Shalyatantra unit 3 Room no 4 Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedge12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical College And Hospital Urun Islampur Dist Sangli 415409 india |
|
|
Primary Sponsor
|
| Name |
LRP Ayurvedic Hospital And Research Centre |
| Address |
LRP Ayurvedic Medical College And Hospital Post Graduate Institute And Research Centre Islampur Sangli Maharashtra India Pin code-415409 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sweety Undirwade |
LRP Ayurvedic College and Hospital Post Graduate Institute And Research Centre |
Department of Shalyatantra Unit no 3 Room no 4 LRP Ayurvedic College And Hospital Urun Islampur Sangli 415409
Sangli
MAHARASHTRA |
9404410554
1822sweet@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jyotishmati beeja kalka lepa , Reference: Yogratnakar arsharogadhikar 4, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Haritaki choorna 2gm with warm water for 10days | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Haridradi lepa , Reference: Bhavprakash chikitsa prakaran 5/57arsha rogadhikar , Route: Topical, Dosage Form: Kalka/ Paste , Dose: 2(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 10 Days, anupAna/sahapAna: No, Additional Information: Haritaki choorna 2gm with warm water for 10days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients age 18-60 years
2.Patients having fulfilling criteria for diagnosis of internal haemorrhoids such as PR bleeding I degree and II degree constipation protrusion of mass.
3.Patients will be selected irrespective of sex
and socioeconomic status and religion |
|
| ExclusionCriteria |
| Details |
1.External thrombosed and strangulated
haemorrhoids III and IV degree.
2.Haemorrhoids associated with fissure,fistula-in-
ano,malignancy of rectum and anal canal rectum
prolapsed,CA prostate,peptic ulcers,AIDS
Kochs,liver disease,liver cirrhosis.
3.Pregnant and lactating women.
4.Systemic disorders such as DM,Anemia,bleeding
disorder(Coagulopathy),HTN. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Study The Efficacy Of Jyotishmati Beeja Kalka Lepa In The Management Of Raktarsha With Special Reference To I And II Degree Internal Haemorrhoids |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of ayurvedic formulation |
10 days with f/o after 15th and 20th days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
13/09/2024 |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [1822sweet@gmail.com].
- For how long will this data be available start date provided 21-10-2024 and end date provided 20-10-2029?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This is Randomized Controlled Clinical trial to study the efficacy of Jyotishmati Beeja Kalka Lepa In the management of Raktarsha with special reference to I and II degree Internal Haemorrhoids. Jyotishmati beeja kalka lepa and haridradi lepa both are antiinflammatery, vednasthapana, vatahara properities. the age group taken for study trail will be between 18-60 years .ayurvedic formalation will be given for 10 days and f/o after 15th and 20th days . evaluation of no PR bleed effect of both groups using statistical tools will be done and conclusion will be made. |