| CTRI Number |
CTRI/2023/11/060201 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
14/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
A Clinical study to evaluate efficacy of Patoladi Gana ghrita Pichu & Yashtimadhu ghrita Pichu in the management of Parikartika W.S.R.to Acute Fissure in Ano |
|
Scientific Title of Study
|
A Clinical trial of Patoladi gana ghrita pichu & Yashtimadhu ghrita pichu in the management of Parikartika w.s.r. to Acute 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 Manisha Kashinath Bachhav |
| Designation |
Ph.D.Scholar Shalya Tantra Department |
| Affiliation |
Loknete Rajarambapu Patil Ayurvedic college and PG institute Islampur |
| Address |
Loknete Rajarambapu Patil Ayurvedic college PG institute and Research centre Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
7058843346 |
| Fax |
|
| Email |
sushrut2217@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Ramchandra Shedage |
| Designation |
Professor |
| Affiliation |
Loknete Rajarambapu Patil Ayurvedic college Islampur |
| Address |
Loknete Rajarambapu Patil Ayurvedic medical college Hospital & Research Institute Shalya Tantra OPD no 9 Islampur Taluka Walwa District Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Ramchandra Shedage |
| Designation |
Professor |
| Affiliation |
Loknete Rajarambapu Patil Ayurvedic college Islampur |
| Address |
Loknete Rajarambapu Patil Ayurvedic medical college Hospital & Research Institute Shalya Tantra OPD no 9 Islampur Taluka Walwa District Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888944733 |
| Fax |
|
| Email |
amit.shedage12@gmail.com |
|
|
Source of Monetary or Material Support
|
| LRP Ayurvedic college Islampur |
|
|
Primary Sponsor
|
| Name |
Loknete Rajarambapu Patil Ayurvedic college and PG institute |
| Address |
Loknete Rajarambapu Patil Ayurvedic college PG institute and Research centre Islampur Taluka Walwa District Sangali |
| 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 Manisha Kashinath Bachhav |
Loknete Rajarambapu Patil Ayurvedic college Hospital Islampur |
Loknete Rajarambapu Patil Ayurvedic medical college Hospital & Research Institute Shalya Tantra OPD no 9 Islampur Taluka Walwa District Sangli
Sangli
MAHARASHTRA |
7058843346
sushrut2217@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Loknete Rajarambapu Patil Ayurvedic college Islampur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | sarpiH, सरà¥à¤ªà¤¿à¤ƒ | (Procedure Reference: Sushrut Samhita Chikitsasthan 1/8&9, Procedure details: A Cottan Swab (pichu) soaked in 5 ml of Patoladi Gana Ghrita will be applied for 15 minutes,twice a day for 15 days)
(1) Medicine Name: Patoladi Gana Ghrita, Reference: Sushrut Samhita Sutrasthan 38/34, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | sarpiH, सरà¥à¤ªà¤¿à¤ƒ | (Procedure Reference: Sushrut Samhita Chikitsathan1/8 &9, Procedure details: A cotton swab (pichu) socked in 5 ml Yashtimadhu Ghrita will be applied locally for 15 minutes, twice a day for 15 days)
(1) Medicine Name: Yashtimadhu Ghrita, Reference: Sushrut Samhita Chikitsathan34/16, Route: Topical, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from Parikartika with symptoms of painful defecation burning sensation bleeding per rectum |
|
| ExclusionCriteria |
| Details |
Patients having Chronic fissure in ano ArshaBhagandar Gudagat Arbud Gudvidradhi Diabetes Mellitus HIV Hepatitis B Coagulopathies Bleeding Disorders Anaemia etc |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| relife from symptoms like Guda Shoola, GudaDaha, Guda kandu, Raktasrava, Malavshthmbha |
On 0 5 10 & 15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| relife from sign like Vrana Size ,Assesement of Sphincter spasm |
on 22 & 29 day |
|
|
Target Sample Size
|
Total Sample Size="224"
Sample Size from India="224"
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)
|
01/12/2023 |
| 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
|
It is randomised, controlled clinical trial.it will be assess the efficacy of Patoladi Gana Ghrita pichu & Yashtimadhu Ghrita pichu in the management of Parikartika (Acute Fissure in Ano). Trial will be conduced on patients having symptoms of Parikartika to assess the effects of two ghrita in relife of symptoms of Parikartika.The duration of tretement will be 15 days. Primary endpoint will be relife in symptoms like Guda Shool,Gudadaha,Guda Kandu,Raktasrava,Malavshathmbha etc.Secondary endpoint will be reduction in size of fissure and sphincter spasm. |