| CTRI Number |
CTRI/2024/11/077089 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/11/2024 |
| 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 study the add on effect of
Nyagrodhadi Tail Pooran with Apamarga Ksharsutra in the
Management of Bhagandara.
|
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to Evaluate add on effect of
Nyagrodhadi Tail Pooran with Apamarga Ksharsutra in the
Management of Bhagandara.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrAmrapali Rajvilas Lade |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College Of Ayurved And Research Centre |
| Address |
PDEAs College Of Ayurved And Research Centre Third floor,
Shalyatantra Department, Sector no. 25, pradhikaran, Nigdi,Pune Maharashtra 411044
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8554021805 |
| Fax |
|
| Email |
amrapalilade5@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kiran Mendhekar |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College Of Ayurved And Research Centre |
| Address |
PDEAs College Of Ayurved And Research Centre Third floor,
Shalyatantra Department, Sector no. 25, pradhikaran, Nigdi, Pune Maharashtra 411044
Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9867802319 |
| Fax |
|
| Email |
doctor.kiran.mendhekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kiran Mendhekar |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College Of Ayurved And Research Centre |
| Address |
PDEAs College Of Ayurved And Research Centre Third floor,
Shalyatantra Department, Sector no. 25, pradhikaran, Nigdi,Pune Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9867802319 |
| Fax |
|
| Email |
doctor.kiran.mendhekar@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEA college Of Ayurveda and Research Centre Nigdi Pune Maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs College Of Ayurved And Research Centre Nigdi Pune |
| Address |
PDEAs College Of Ayurved And Research Centre Third floor,
Shalyatantra Department, Sector no. 25, pradhikaran, Nigdi,Pune Maharashtra 411044
|
| 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 Amrapali Rajvilas Lade |
Ayurved Rugnalaya And Sterling Multispeciality hospital Nigdi Pune |
PDEAs College Of
Ayurved And Research
Centre Shalyatantra
Department Third Floor
Nigdi Pune
Maharashtra 411044
India
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8554021805
amrapalilade5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee College of Ayurveda and Research Centre Akurdi Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pUraNa-karma, पूरण-करà¥à¤® | (Procedure Reference: Sushrut Chikitsasthan, Procedure details: Ksharsutra Parivartan Done Under Aspectic Precation Pooran oF Sterilised Koshna Nyagrodhadi Tail into the track. According to depth of track quantitatively Sufficient tail will be Infiltrate into the track with the help of syringe attached to infant feeding tube no.6 until the track heals than Dressing will be Done. Ksharsutra will be change once in a Week & progress will be Assessed on Weekly Basis.)
(1) Medicine Name: Nyagrodhadi Tail, Reference: Sushrut Chikitsasthan, Route: Rectal, Dosage Form: Taila, Dose: 5(ml), Frequency: od, Duration: 4 Months | | 2 | Comparator Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: Sushrut Chikitsasthan, Procedure details: Under aspectic Precaution Fistula Tract irrigated with Betadine Soiution Tract clean Properly.old Ksharsutra will be Removed After Cleaning the Track & replacing it with a new ksharsutra.The New thread will be Placed inside the fistula track & secured to allow Proper healing & drainage. )
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of Fistula-in-Ano.,
Patients will be selected Irrespective of Sex, Prakriti, Operative recurrence.
|
|
| ExclusionCriteria |
| Details |
Patients who are suffering with systemic diseases like Tuberculosis, Ulcerative Colitis, Osteomyelitis of Coccyx, Carcinoma of Rectum, malignancy, uncontrolled 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 |
| The effect of nyagrodhadi tail pooran with apamarga ksharsutra will be accessed with the apamarga ksharsutra in bhagandara after 28 day assessment will be done by criteria like pain iching ,discharge & unit cutting time |
Patient will be followed up on 7th,14th ,21st,28 day. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The meaning of Bhagandar is Daruna in bhaga ,guda,basti pradesh, which means splitting up pircing up of perianal region. The condition in pre suppurative stage known as pidika and suppurative stage is known as Bhagandara.The anal fistula is communicating track lined by unhealthy granulation tissue with an external opening in the skin of perianal region and an internal opening in the modified skin or mucosa of anal canal or rectum. Fistula in ano is major disease of anorectal region and is characterized by persistent pus discharge associated with intermittent pain. As per the reference of Sushrut in Bhagandara Chikitsa Adhyaya quoted that by infiltrating oil into the fistula track which heals faster. Hence selected Nyagrodhadi tail poorana, as this taila has the properties of Vrana sodhana ropana,Vedanasthapak, properties of drug present in it as mentioned in Sushruta Samhita. So, to enhance the healing of fistulous track and to reduce the post adverse effects of ksharsutra management the present topic is selected for study. |