| CTRI Number |
CTRI/2023/08/056484 [Registered on: 14/08/2023] Trial Registered Prospectively |
| Last Modified On: |
02/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study of doorva tail application in anal canal for healing the fissure in ano |
|
Scientific Title of Study
|
Open randomized controlled clinical trials to evaluate the efficacy of doorva taila gudapuran in management of parikartika with special reference to 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 Sonal Suresh Kad |
| Designation |
PG Scholar |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
OPD no 13 Shalya Tantra OPD Ground Floor Dhanvantari Ayurved
Hospital Ashta Tal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9763895761 |
| Fax |
|
| Email |
kadsonal04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Jadhav |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center AshtaTal Walwa Dist Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9823279290 |
| Fax |
|
| Email |
sjadhav21066@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Jadhav |
| Designation |
Reader |
| Affiliation |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
| Address |
3rd Floor Department of Shalya Tantra Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center AshtaTal Walwa Dist Sangli
MAHARASHTRA
416301
India |
| Phone |
9823279290 |
| Fax |
|
| Email |
sjadhav21066@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center ashta |
|
|
Primary Sponsor
|
| Name |
Dr Sonal Suresh Kad |
| Address |
OPD no 13 Shalya Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal walwa Dist Sangli |
| 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 Sonal Suresh Kad |
Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta |
OPD no 13 Shalya Tantra OPD Ground Floor Dhanvantari Ayurved Hospital Ashta Tal WalWa Dist Sangli
Sangli
MAHARASHTRA |
9763895761
kadsonal04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hon Shri Annasaheb Dange Ayurved Medical College Post Graduate and Research Center Ashta Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: fissure, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushruta Samhita, Procedure details: once in a day for 7 days)
(1) Medicine Name: Yashtimadhu Tail, Reference: Sushruta Samhita, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH, मातà¥à¤°à¤¾à¤¬à¤¸à¥à¤¤à¤¿à¤ƒ | (Procedure Reference: Sushruta Samhita, Procedure details: once in a day for 7 days)
(1) Medicine Name: Doorva Tail, Reference: charak samhita, Route: Rectal, Dosage Form: Taila, Dose: 10(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having Lakshana with Parikartika acute and chronic fissure in ano |
|
| ExclusionCriteria |
| Details |
1 Severe immune compromised patients
2 Patients with uncontrolled systemic disease like
diabetes
3 Patients having parikartika secondary to
ulcerative colitis syphilis crohns disease
tuberculosis will be excluded
4 Patient with known case of CA rectum will be
exclude |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1 To determine the efficacy of Doorva tail gudapuran in the management of parikartika |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To evaluate the efficacy of doorva tail gudapuran on the sign & symptom of parikartika
2 To compare the effect of doorva tail & yashtimadhu taila |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
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)
|
29/08/2023 |
| 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="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
|
As we see the number of patients with fissure in ano are increased now a day so this study will help the patients for better healing of fissure. Open randomized controlled clinical trials to evaluate the efficacy of doorva taila gudapuran as trial drug and yashtimadhu tail as control drug. Trial and control drug will be applied in the form of Taila in Anal Canal i.e. Gudapurana in the diagnosed cases of Parikartika with Special Reference to Fissure in Ano for 7 days. After 7 days patient is advice to come on 10 th day for follow up. 42 patients in each group will be studied. Study will be conducted in India. Outcome of study will be assess on better healing of fissure in ano and reduction of signs and symptoms of fissure in ano.
|