| CTRI Number |
CTRI/2024/12/077782 [Registered on: 06/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Lajjalu siddh tail and Lidocain 2 percent jelly local application in the treatment of parikartika (Fissure in Ano) |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial To Evaluate The Efficacy Of Lajjalu (Mimosa pudica) Siddha Taila With Lidocaine 2 percent Jelly Local Application In Parikartika (Fissure- In-Ano) |
| 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 Arpit Gupta |
| Designation |
PG Scholar Shalyatantra |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre Pimpri Pune 18 |
| Address |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
8960165045 |
| Fax |
|
| Email |
arpit123g@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka D Patil |
| Designation |
M.S. (Shalyatantra) PhD (Scholar) |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre |
| Address |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
Pune
MAHARASHTRA
411018
India |
| Phone |
7517006163 |
| Fax |
|
| Email |
priyankap044@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka D Patil |
| Designation |
M.S. (Shalyatantra) PhD (Scholar) |
| Affiliation |
Dr D Y Patil College of Ayurved And Research Centre |
| Address |
OPD No 3 And IPD Shalyatantra of Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune 18
MAHARASHTRA
411018
India |
| Phone |
7517006163 |
| Fax |
|
| Email |
priyankap044@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D Y Patil college of Ayurved and Reseach Centre Sant Tukaram Nagar Pimpri Pune Maharashtra 411018 |
|
|
Primary Sponsor
|
| Name |
Dr Arpit Gupta |
| Address |
Dr D Y Patil College of Ayurved And Research Centre Sant Tukaram Nagar Pimpri Pune Maharashtra India 411018 |
| 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 Arpit Gupta |
Dr D Y Patil college of Ayurved and Research Centre Pimpri Pune |
OPD no 3 And IPD of shalyatantra department
Pune
MAHARASHTRA |
8960165045
arpit123g@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DR DYPCA AND RC Institutional Ethics Committee |
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: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | picu, पिचॠ| (Procedure Reference: ch chikitsa 19/46, Procedure details: A Small piece of cotton will be taken and it will be soaked in lajjalu sidhha taila and will be placed on the anal verge (Ulcer) once a day at night upto 7 days)
(1) Medicine Name: lajjalu siddh taila, Reference: su sutra 38/47, Route: Topical, Dosage Form: Taila, Dose: 3(ml), Frequency: hs, Duration: 7 Days | | 2 | Comparator Arm (Non Ayurveda) | | - | lidocaine 2 percent jelly local application | clean the anal verge with normal saline and dried with gauze piece and then after lidocaine 2 percent jelly applied for 7 days once a day in night |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having following signs and symptoms
Longitudinal ulcer (Vrana) in the Anal region with Guda shool (Anal pain) during and after defecation.
Gudagata Raktasrava (Bleeding per Rectum).
Anal spasm
|
|
| ExclusionCriteria |
| Details |
Patients on Anti-Coagulant medicine
Patients with Uncontrolled Diabetes Hypertension
Patients with history of Severe Anaemia Crohns disease Ulcerative colitis Pregnancy
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Assess the effect of Lajjalu (Mimosa Pudica) Siddha taila Loacal Application in pain in Parikartika (Fissure-in-Ano) |
Day 0 (After Assessment) Lajjalu siddha taila will be given for local application this same medicine will be giving to patient for local application upto 7 days (12 hourly) and assesment will be done on day 3rd 5th and 7th
Concomitant drugs will be given that is 2 tablets Gandharv haritaki vati 250mg HS with Luke-warm water and hot sitz bath |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the effect of Lajjalu (Mimosa Pudica) Siddha taila in bleeding and wound healing in Parikartika (Fissure-in-Ano) |
Day 0 (After Assessment) Lajjalu siddha taila will be given for local application this same medicine will be giving to patient for local application upto 7 days (12 hourly) and assesment will be done on day 3rd 5th and 7th |
|
|
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)
|
04/02/2025 |
| 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 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
|
Patients will be screened from O.P.D. and I.P.D. of Dr. D. Y. Patil College of Ayurved and Research Centre, Pimpri, Pune. Only those patients who will fulfill the eligibility criteria will be enrolled. Patients will be informed about the purpose and the schedule of the study at the time of enrollment. Written informed consent will be obtained and case record form will be filled. First local application of medicine will given to both group after assessment and medicine will be given to patient for local application upto 7 days once a day at night Concomitant drugs will be given to both groups that is 2 tablets Gandharv haritaki vati 250mg HS with Luke-warm water and hot sitz bath and follow up will be taken on 3rd , 5th and 7th day total of 60 patient will be taken for study (30 patient each group)
|