| CTRI Number |
CTRI/2019/09/021409 [Registered on: 25/09/2019] Trial Registered Prospectively |
| Last Modified On: |
22/09/2019 |
| 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
|
Use Of Kadamba Ointment In The Mananagment Of Fissure In Ano(Parikartika) |
|
Scientific Title of Study
|
Randomized Controlled Trial Of Kadamba Ointment In The Management Of Parikartika (Fissure In Ano). |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajesh Tukaram Khandagale |
| Designation |
PG Shalyatantra Scholar |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Shalya Tantra Department,Government Ayurved College and Hospital,Raje Raghuji Nagar,Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9503070358 |
| Fax |
|
| Email |
rajeshkhandagale94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nita M Kedar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Shalya Tantra Department,Government Ayurved College and Hospital,Raje Raghuji Nagar,Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nita M Kedar |
| Designation |
Associate professor |
| Affiliation |
Government Ayurved College and Hospital Nagpur |
| Address |
Shalya Tantra Department,Government Ayurved College and Hospital,Raje Raghuji Nagar,Nagpur.
Nagpur
MAHARASHTRA
440024
India |
| Phone |
9422117613 |
| Fax |
|
| Email |
drnita6@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of ShalyaTantra department Government Ayurved College and Hospital Nagpur. |
|
|
Primary Sponsor
|
| Name |
self Rajesh Tukaram Khandagale |
| Address |
Shalya Tantra Department Government Ayurved College and Hospital,Raje Raghuji Nagar,Nagpur. |
| 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 |
| Rajesh Tukaram Khandagale |
Government Ayurved College and Hospital Nagpur |
Shalya Tantra Department,Government Ayurved College and Hospital,Raje Raghuji Nagar,Nagpur.
Nagpur
MAHARASHTRA |
9503070358
rajeshkhandagale94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics comitee Government Ayurved College and Hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Jatyadi Ghrita |
1.Informed consent of patient will be taken.
2.Patient will be taken on the examination table.
3.Careful local examination of anal region of patient will be done.
4.The anal site will be cleaned with betadine .
5.Application of Jatyadi Ghrita will be done twice a day for 10 days.
6.All other precautions and instructions for avoiding infection will be given to patient.
7.Proper dietary regimen will be adviced.
8.Sitz bath will be advised twice daily.
9.Gandharva Haritaki Churn 5 gram HS (bed time) will be given for relieve constipation.
10.Follow up on 0, 3rd , 5th , 7th , 10th ,12th and 15th day of treatment will be taken.
|
| Intervention |
Kadamba Ointment |
1.Informed consent of patient will be taken.
2.Patient will be taken on the examination table.
3.Careful local examination of anal region of patient will be done.
4.The anal site will be cleaned with betadine .
5.Application of Kadamba ointment will be done twice a day for 10 days.
6.All other precautions and instructions for avoiding infection will be given to patient.
7.Proper dietary regimen will be adviced.
8.Sitz bath will be advised twice daily.
9.Gandharva Haritaki Churn 5 gram HS (bed time) will be given for relieve constipation.
10.Follow up on 0, 3rd , 5th , 7th , 10th ,12th and 15th day of treatment will be taken.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients willing to participate in study
2) Patients having age between 18 to 60 yrs.
3) Patients will be selected irrespective of sex, marital status, religion, educational and economical status.
4) Patients having acute and Chronic Fissure in ano.
5) Co-operative patients.
|
|
| ExclusionCriteria |
| Details |
1) Patients not willing to participate in the study.
2) Patients of Fissure in ano associated with Haemorrhoids and Fistula in ano.
3) Patients with Ca Rectum.
4) Immunocompromised patients.
5) Non co-operative patients.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of Kadamba ointment and Jatyadi ghrita in Parikartika (Fissure in ano). |
One and half year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To study the effect of Kadamba ointment with special reference to its Vedanasthapan , Shodhan and Ropan properties. |
18 Months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 |
|
Date of First Enrollment (India)
|
01/10/2019 |
| 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
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The peoples having complaint of constipation may suffer from fissure in ano. The symptoms of fissure in ano are like symptoms of Parikartika. As pain is most troublesome complaint hence pain management in fissure in ano is most important and along with pain healing of that ulcer is also important component while treating fissure in ano. In modern science Non steroidal anti inflammatory drugs (NSAID)are being used for pain management. But it has its own limitations so we need the drug which will not harmful to body and which manage the disease without any complication. Kadamba is mentioned in Vedanasthapana Gana by Charaka and in Nyagrodhadi gana by Sushruta. Taking this into consideration pain and healing can be achieve by using Kadamba and no research work has been found on Kadamba regarding managment of Parikartika. 100 subject will be equally randomized to experimental and control group. Sampling technique Simple random method will be used . Patients having acute and Chronic Fissure in ano will be taken for study. The drug of trial group Kadamba ointment and control group Jatyadi ghrita will be applied on fissure in ano by using same standard operating procedure. Follow up on 0, 3rd , 5th , 7th , 10th ,12th and 15th day of treatment will be taken in both trial and control group. According to the data acquired through this study discussion will be done. All results will be put forth in detail as per results obtained by application of data will be analyzed and express statistically. |