| CTRI Number |
CTRI/2023/04/051688 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
06/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of taila prepared with Tagara and other medicinal drugs in Fissure in ano. |
|
Scientific Title of Study
|
A Clinical study of Kalanusaryadi Taila in the management of Parikartika w.s.r. to 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 |
Nilima Pandey |
| Designation |
MS Scholar Shalya Tantra |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurvedic College Raipur C.G. |
| Address |
OPD NO.15 Department of Shalya Tantra Shri Khudad Dungaji Govt Ayurveda Hospital Raipur Chhattisgarh Shri NPA Govt.Ayurveda College Raipur C.G.492010 India.
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur C.G.
Raipur
CHHATTISGARH
492010
India |
| Phone |
8435172873 |
| Fax |
|
| Email |
pandeynilima91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Balendra Singh |
| Designation |
Proffesor Shalya Tantra |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda college Raipur C.G. |
| Address |
OPD NO. 15 Shalya Tantra Department Shri Khudad Dungaji Govt Ayurveda Hospital Raipur C.G.Shri NPA Govt Ayurveda College Raipur C.G.492010 India.
Shri N.P.A Govt.Ayurveda College Campus Raipur C.G.
Raipur
CHHATTISGARH
492010
India |
| Phone |
9039180335 |
| Fax |
|
| Email |
drbalendrasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Satrupa Nirmal |
| Designation |
Lecturer Shalya Tantra |
| Affiliation |
Shri Narayan Prasad Awasthi Govt. Ayurveda college Raipur C.G. |
| Address |
OPD NO.15 Shalya tantra department shri Khudad Dungaji Govt Ayurveda Hospital Raipur c.g.SHRI NPA Govt Ayurveda College Raipur C.G 492010 India.
Shri Narayan Prasad Awasthi Govt. Ayurveda College Raipur C.G.
Raipur
CHHATTISGARH
492010
India |
| Phone |
9301088046 |
| Fax |
|
| Email |
rupa.nirmal1985@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri NPA Government Ayurveda College Raipur Chhattisgarh 492010 |
|
|
Primary Sponsor
|
| Name |
Shri NPA Govt Ayurved College Raipur Chhattisgarh |
| Address |
Shri NPA Govt Ayurved College Raipur Chhattisgarh |
| Type of Sponsor |
Other [Shri NPA Govt Ayurveda College Raipur Chhattisgarh.] |
|
|
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 |
| Nilima Pandey |
Shri Khudad Dungaji Ayurveda Hospital Raipur C.G. |
opd no 15 Department of shalya tantra Govt. Ayurveda Hospital Raipur C.G.
Raipur
CHHATTISGARH |
8435172873
pandeynilima91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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, (2) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: fissure in ano, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Kalanusaryadi taila, Reference: Sushruta Samhita, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Panchsakar churna 5 gm before meal at night daily. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Taila, Reference: Sharangdhara Samhita, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -Panchsakara churna 5 gm before meal at night daily. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient who will be diagnosed suffering with parikartika,excruciating pain,in anal region during and after defecation,bleeding per annum,constipation,burning sensation,longitudinal ulcer.2)acute solitary fissure will be included.3)Fissure in ano with sentinal piles. |
|
| ExclusionCriteria |
| Details |
1)Patient below the age of 18 yrs and above the age of 60 years.2)fissure in ano associated with ano rectal abscess.3)fissure in ano associated with fistula in ano.4)fissure in ano associated withtuberculosis,anal malignancy.5)Immunological disease like crohns disease ,ulcerative colitis.6)STDs, HIV,HBSAg,Hepatitis.7)uncontrolled case of diabetes mellitus and hypertension,9)Pregnant woman. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fissure in ano will be relieved by applying kalanusaryadi taila within 4 Weeks. |
kalanusaryadi taila will be applied in fissure in ano for 1 month and follow up will be done once in a week for 1 month or upto the complete healing of fissure in ano. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Other associated symptoms like excruciating pain,streak like bleeding will be relieved within 4 weeks. |
Kalanusaryadi taila will be applied in fissure in ano for 1 month and follow up will be done once in a week for 1 month or upto the complete healing of fissure in ano. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2023 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Due to sedentary life style of people Fissure in ano is the most commonest problem.It disturbs the physical as well as mental well being of people due to excruciating pain,bleeding,constipation. Acharya sushruta has mentioned many vran ropaka tails among them Kalanusaryadi taila is very helpful for healing the fissure and subsiding the pain and bleedding.It contains various vran ropak and vedna shamaka drugs which help to get relief from fissure in ano. |