| CTRI Number |
CTRI/2025/05/086546 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
07/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Study The Rujahar Effect Of Patha- Yavasa Churna In The Management Of Arsha. |
|
Scientific Title of Study
|
Single arm clinical trial to study the effect of patha-yavasa churna in the management of arsha with special reference to 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 Monali Yesulal Uprade |
| Designation |
PG Scholar |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalyatantra OPD no.4 SMBT Ayurved College And Hospital Nandi Hills Dhamangaon,Igatpuri
Nashik
MAHARASHTRA
422403
India |
| Phone |
7028786195 |
| Fax |
|
| Email |
monaliuprade31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Premchand Badhe |
| Designation |
Professor |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalyatantra OPD no.4 SMBT Ayurved College And Hospital Nandi Hills Dhamangaon,Igatpuri
Nashik
MAHARASHTRA
422403
India |
| Phone |
9689339928 |
| Fax |
|
| Email |
adkpc74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monali Yesulal Uprade |
| Designation |
PG Scholar |
| Affiliation |
SMBT Ayurved College And Hospital |
| Address |
Department of Shalyatantra OPD no.4 SMBT Ayurved College And Hospital Nandi Hills Dhamangaon,Igatpuri
Nashik
MAHARASHTRA
422403
India |
| Phone |
7028786195 |
| Fax |
|
| Email |
monaliuprade31@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Ayurved College And Hospital Nandi hills dhamangon,igatpuri,Nashik Maharashtra 422403 |
|
|
Primary Sponsor
|
| Name |
Dr Monali Yesulal Uprade |
| Address |
Department Of Shalyatantra OPD no4 SMBT AYUrved COllege And Hospital Nandi Hills Dhamangaon,Igatpuri, Nashik, Maharashtra, 422403 |
| 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 Monali Yesulal Uprade |
SMBT College And Hospital |
Department of Shalyatantra OPD no.4 SMBT Ayurved College And Hospital Nandi Hills Dhamangaon,Igatpuri
Nashik
MAHARASHTRA |
07028786195
monaliuprade31@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College And Hospital |
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: Patha-Yavasa Churna, Reference: Yogratnakara with ‘vidyotini’ Hindi commentary by Vaidya lakshmipati sastri, edited by Bhisagratna brahmasankar sastri, Chaukhamba Prakashan Varanasi , arsharoganidanam, page no 305 shlok no. 8., Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -koshana jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients Age - 18 to 60 years.
2.Patients having fulfilling criteria for diagnosis of internal haemorrhoids such as pain, PR Bleeding, constipation, Protrution of mass.
3.Patient will be selected irrespective of Sex and socioeconomic status and religion
|
|
| ExclusionCriteria |
| Details |
1.Pateint below age 18 year and above 60 years.
2.External, Thrombosed & strangulated Haemorrhoids..
3.Haemorrhoids associated with fissure in-ano,fistula in-ano, malignancy of rectum and anal canal, rectal prolapsed, etc. CA prostate, peptic ulcers, AIDS, Koch’s, liver disease, liver cirrhosis.
4.Pregnant and lactating women.
5.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 rujahar effect of patha - yavasa choorna in the management of arsha with special reference to haemorrhoid . |
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the effect of ayurvedic formulation. |
7 days with f/u after 10 days. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/05/2025 |
| 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
|
This is single arm Clinical trial to study the effect of Patha- Yavasa churna in the management of arsha with special reference to Haemorrhoids. Patha - Yavasa churna both are antiinflammatery, vednasthapana, vatahara and raktasthambhana properities. the age group taken for study trail will be between 18-60 years. ayurvedic formulation will be given for 7 days and f/o after 10th day. Evaluation of rujahar effect of both groups using statistical tools will be done and conclusion will be made. |