| CTRI Number |
CTRI/2024/10/076020 [Registered on: 29/10/2024] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to find out how effective shatadhouta ghrita pichu in parikartika. |
|
Scientific Title of Study
|
A single arm clinical trial to study the effect of shatadhouta ghrita pichu local application in parikartika. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pranjal Sanjay Narwade |
| Designation |
PG Student |
| Affiliation |
SMBT Ayurved College And Hospital Dhamangaon Igatpuri Nashik |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Dhamangaon Nashik
Maharashtra 422403 India
Nashik
MAHARASHTRA
422403
India |
| Phone |
08766894571 |
| Fax |
|
| Email |
pranjalnarwade123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shilpa Premchand Badhe |
| Designation |
Professor |
| Affiliation |
Department of Shalyatantra SMBT Ayurved College and Hospital Dhamangaon Nashik Maharashtra 422403 |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Dhamangaon Nashik
Maharashtra 422403 India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9689339928 |
| Fax |
|
| Email |
adkpc74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pranjal Sanjay Narwade |
| Designation |
PG student |
| Affiliation |
SMBT Ayurved College And Hospital Dhamangaon |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital Dhamangaon Nashik
Maharashtra 422403 India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8766894571 |
| Fax |
|
| Email |
pranjalnarwade123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalyatantra SMBT Ayurved college and Hospital Dhamangaon, Nashik Maharashtra 422003 India |
|
|
Primary Sponsor
|
| Name |
Dr Pranjali Sanjay Narwade |
| Address |
Department of Shalyatantra SMBT Ayurved College and Hospital,Dhamangaon, Nashik
Maharashtra 422403 India. |
| Type of Sponsor |
Other [] |
|
|
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 Pranjali Sanjay Narwade |
SMBT Ayurved College And Hospital |
Department of Shalyatantra SMBT Ayurved College and Hospital Dhamangaon Nashik
Maharashtra 422403 India
Nashik
MAHARASHTRA |
8766894571
pranjalnarwade123@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:K00-K95||Diseases of the digestive system. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | picu, पिचॠ| (Procedure Reference: Sushrut sutrasthan 13/19 , Procedure details: Pichu is made up of cotton swab 2-3 cm is wrapped with gauze piece & tied with long thread . It is immersed in shatadhouta ghrita.
Duration of pichu dharan 3-4 hours
)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Clinically diagnosed cases of Parikartika were taken for the study.
2)Patients irrespective of sex, religion,Occupation & economic status.
3)Patients of both the sexes in between the age group of 18 to 60 years.
|
|
| ExclusionCriteria |
| Details |
1)Patients having Parikartika (Fissure-in-Ano) secondary to Ulcerative colitis, shyphilis, Crohn’s disease, Tuberculosis and malignancy of rectum and anal Canal
2)Patients with infectious diseases like HIV& HbsAg.
3)Patient with Diabetes, Hypertension and Skin disease.
4)Patients with chronic sentinel pile and associated with conditions like Hemorrhoids and Fistula-in- ano
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of sign and symptoms of Parikartika. |
10 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Parikartika healing rate |
2 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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 3 |
|
Date of First Enrollment (India)
|
15/11/2024 |
| 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="0"
Months="2"
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
|
The condition Fissure-in-ano, commonly encountered in ano rectal practice has similar location, pathology and predominance features of parikartika like excruciating pain, constipation, stool streaked blood etc. In Ayurveda a successful management of this condition has been described. The treatment of parikartika depends on pacifying vata and pita dosha and the treatment told in classics for this condition are Pichabasthi, Anuvasanbusti, Pichu, prisheka and local administration of snehadravyas. Medicated ghrita as local application is mentioned in Ayurvedic classics for parikartika. In this shatdhouta Ghrita were selected fer local applican are having ettective shodhana and ropana properties. Ayurveda provides many treatment options for Parikartika, among them Shatadhouta ghrita pichu local application is most effective. It is simple and easy procedure that can be done at OPD level and at home. Conducting research to evaluate effect of Shatadhouta ghrita pichu in Parikartika is crucial for expanding our understanding of traditional remedies and their application in modern Healthcare. By filling the knowledge gap, the study can provide valuable insights into potential effects of local application of pichu in Parikartika. Including patients within age group of 18-60 years, who fullfill clinical diagnostic criteria for Parikartika. Patients are selected irrespective of sex, socio economic status and community helps in achieving a disease and representative sample, enhancing the generalisability of the study findings, written consent from patients ensures ethical compliance and transparency in the treatment process. Total 15 number of patients will be selected and taken. All SOP of pichu will be strictly followed during and after the procedure. Observation will be done after procedure and follow up after treatment is on 10th day. Result of study will drawn on the basis of criteria of assessment and statistical analysis. Discussion will be done on the basis of observations and result obtained during treatment. Summary will be drawn and whole thesis work will be summarised. Conclusion will be drawn strictly on the basis of statistical analysis and will be unbised. |