| CTRI Number |
CTRI/2025/06/088433 [Registered on: 09/06/2025] Trial Registered Prospectively |
| Last Modified On: |
07/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Understanding the Healing effect of Kadali
pratisarneeya kshara in the management of arsha. |
|
Scientific Title of Study
|
Randomised Controlled Clinical Trial To Evaluate The Efficacy Of Kadali Pratisarneeya Kshara In The Management Of Arsha (Second 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 Ashwini Bhausaheb Patil |
| Designation |
PG Scholar Shalyatanra |
| Affiliation |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi |
| Address |
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7517039363 |
| Fax |
|
| Email |
ashwini.patil12467@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Rajesh Nivruttirao Gundre |
| Designation |
Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi |
| Address |
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9518548733 |
| Fax |
|
| Email |
rgundre200@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini Bhausaheb Patil |
| Designation |
PG Scholar |
| Affiliation |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi |
| Address |
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7517039363 |
| Fax |
|
| Email |
ashwini.patil12467@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 |
| 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 Ashwini Bausaheb Patil |
C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi ,Aurangabad |
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India
OPD NO 16 Shalyatantra Department CSMSS Ayurved Mahavidyalaya And Rugnalaya kanchanwadi Aurangabad Maharashtra India
Aurangabad
MAHARASHTRA |
07517039363
ashwini.patil12467@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CSMSS Ayurved Mahavidyalaya And Rugnalaya Kanchanwadi Aurangabad |
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 | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Shushrut Samhita Ayurveda Dr Ambikadutta Shashtri Sutrasthan Adhyaya 11th Shlok no 20 and Shushrut Samhita Ayurveda Dr Ambikadutta Shashtri Chikitsasthan Adhyaya 6th Shlok no 4, Procedure details: Patient of second degree internal haemorrhoids after confirming the adequate investigation according to inclusive criteria patient will be given proctoclysis enema a night before the actual procedure After a complete rectal evacuation the patient will be taken to the minor OT table Patient will be placed in lithotomy position Perianal region will be cleaned & lubricated and proctoscope will be introduced in the anal canal & position of pile mass will be noted Anal canal will be cleaned by gauze piece A wet sterile cotton ball will be place just behind the internal haemorrhoids to preserve the healthy tissues Kshara will be applied by using a spatula without rubbing to the internal haemorrhoids which typically appears in bluish purple colour (Pakwa Jambuphala Varna) will be wait and observed for Vakashatamatra Then 5 ml of Pure lemon juice will be poured Cotton ball will be used to drain and wipe the anal canal Then 5 ml of water will be sprinkled to clean & wash the rest particles Then cotton balls will be used to drain liquid content inside the anal canal Proctoscope will be withdrawn)
(1) Medicine Name: Kadali Kshar, Reference: Shushrut Samhita Ayurveda Dr Ambikadutta Shashtri Sutrasthan Adhyaya 11th Shlok no 12, Route: Rectal, Dosage Form: Kshara, Dose: 1(mg), Frequency: od, Duration: 2 Weeks | | 2 | Comparator Arm | Procedure | - | pratisAraNIya-kShAraH, प्रतिसारणीय-क्षारः | (Procedure Reference: Shushrut Samhita Ayurveda Dr Ambikadutta Shashtri Sutrasthan Adhyaya 11th Shlok no 20 and Shushrut Samhita Ayurveda Dr Ambikadutta Shashtri Chikitsasthan Adhyaya 6th Shlok no 4, Procedure details: Patient of second degree internal haemorrhoids after confirming the adequate investigation according to inclusive criteria patient will be given proctoclysis enema a night before the actual procedure After a complete rectal evacuation the patient will be taken to the minor OT table Patient will be placed in lithotomy position Perianal region will be cleaned & lubricated and proctoscope will be introduced in the anal canal & position of pile mass will be noted Anal canal will be cleaned by gauze piece A wet sterile cotton ball will be place just behind the internal haemorrhoids to preserve the healthy tissues Kshara will be applied by using a spatula without rubbing to the internal haemorrhoids which typically appears in bluish purple colour (Pakwa Jambuphala Varna) will be wait and observed for Vakashatamatra Then 5 ml of Pure lemon juice will be poured Cotton ball will be used to drain and wipe the anal canal Then 5 ml of water will be sprinkled to clean & wash the rest particles Then cotton balls will be used to drain liquid content inside the anal canal Proctoscope will be withdrawn)
(1) Medicine Name: Apamarga Kshar, Reference: Shushrut Samhita Ayurveda Dr Ambikadutta Shashtri Sutrasthan Adhyaya 11th Shlok no 12, Route: Rectal, Dosage Form: Kshara, Dose: 1(mg), Frequency: od, Duration: 2 Weeks |
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed patients of Arsha Second degree internal haemorrhoid will be taken foe the study
Patients of age between 16yrs to 70yrs will be taken
Selection of patient will be done irrespective to Religion Gender and Socioeconomic class |
|
| ExclusionCriteria |
| Details |
Known case of 1st 3rd 4th degree Haemorrhoids
Patients having HB less than 8gm percentile
Known case of internal Haemorrhoids associated with other anorectal disorder such as fissure in ano fistula in ano
Patients with bleeding disorders
Patients of Known case of DM HTN Ca rectum Tuberculosis Prolapse of Rectum etc |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Raktastrav Constipation Size of Arshankur reduces on 1st 7th 14th day |
Raktastrav Constipation Size of Arshankur reduces on 1st 7th 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
20/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/06/2025 |
| 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
|
World wide Prevalance rate of Haemorrhois is 4.4 percentileArsha is a common anorectal condition which is on the rise due to factor such as an unhealthy diet and a sedentory lifestyle The treatment of Arsha through Pratisarneeya Kshar offers several advantages it poses minimal risk of recurrent is cost effective causes less pain and bleeding avoids including inflammation and requires only a short hospital stay for care Additionally the drug required for this treatmet is readily available and preparation and application of pratisarneeya kshar are strait forward and uncomplicated
The study will be condected on 92 diagnosed patients with 2 degree internal haemorrhoids Written consent initial assessment The patient will be divided inti 2 groups Trial Group A Kadali Pratisarneeya Kshar Control Group B Apamarga Pratisarneeya Kshar observation and result will be noted Discussion and Conclusion
|