| CTRI Number |
CTRI/2025/05/087503 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use Of Vala (Cuscus Grass/ Vetiver) Ointment IN Fissure |
|
Scientific Title of Study
|
Randomised Controlled Prospective Single Blind Clinical Study Of Ushir Malahar In Management Of Parikartika W.S.R 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 Komal Anantrao Gutte |
| Designation |
PG Scholar |
| Affiliation |
Govt Ayurvedic Collage Tuljapur Naka Dharashiv |
| Address |
Room no 17 Shalyatantra Department Division A second floor Govt Ayurvedic Collage Dharashiv 413501 Maharashtra India
Room no 17 Shalyatantra Department Division A second floor Govt Ayurvedic Collage Dharashiv 413501 Maharashtra India
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
9359544763 |
| Fax |
|
| Email |
Komalgutte03497@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D W Lilke |
| Designation |
Associate professer of Deparment of shalya Tantra |
| Affiliation |
Govt Ayurvedic Collage Tuljapur Naka DharashivGovt Ayurvedic Collage Tuljapur Naka Dharashiv |
| Address |
Room no 17 Shalyatantra Department Division A second floor Govt Ayurvedic Collage Dharashiv 413501 Maharashtra India
Room no 17 Shalyatantra Department Division A second floor Govt Ayurvedic Collage Dharashiv 413501 Maharashtra India
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
9922208586 |
| Fax |
|
| Email |
dhana_lilke@rediffmail.c0m |
|
Details of Contact Person
Public Query
|
| Name |
Dr D W Lilke |
| Designation |
Associate professer of Deparment of shalya Tantra |
| Affiliation |
Govt Ayurvedic Collage Tuljapur Naka DharashivGovt Ayurvedic Collage Tuljapur Naka Dharashiv |
| Address |
Room no 17 Shalyatantra Department Division A second floor Govt Ayurvedic Collage Dharashiv 413501 Maharashtra India
room no 17 Shalyatantra Department Division A second floor Govt Ayurvedic Collage Dharashiv 413501 Maharashtra India
Osmanabad
MAHARASHTRA
413501
India |
| Phone |
9922208586 |
| Fax |
|
| Email |
dhana_lilke@rediffmail.c0m |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic Hospital Dharashiv 413501 |
|
|
Primary Sponsor
|
| Name |
Department of Shalya Tantra |
| Address |
Shalya Tantra OPD 17 Ground Floor Govt Ayurvedic Collage & Hospital,Tuljapur Naka Dharashiv |
| Type of Sponsor |
Other [ Government Ayurvedic College And Hospital Dharashiv] |
|
|
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 |
| DRKomal Anantrao Gutte |
Government Ayurvedic Hospital Dharashiv |
room no 17 Shalya Tantra Department Ground Floor division A Government Ayurvedic college & Hospital Tuljapur Naka Dharashiv 113501 Maharashtra India
Osmanabad
MAHARASHTRA |
09359544763
Komalgutte03497@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K928||Other specified diseases of the digestive system. Ayurveda Condition: BAGANDARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Lidocaine Metronidazole and Sucralfate ointment | Lidocaine Metronidazole and Sucralfate ointment apply localy on fissure in ano. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ushir Malahar, Reference: Charak Samhita Sutrasthan 25 th Adhyay, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 1(g), Frequency: tds, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: No, Route: -, Dosage Form: Malahara/ Ointment/ Balm, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Acute fissure in ano
2) patients with age group 18 to 60 years |
|
| ExclusionCriteria |
| Details |
1)Chronic fissure in ano
2)HIV & Hbsag positive patients
3)CA Rectum ,rectal polyp, prolapsed rectum |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Decreased Burning Pain in Ano
Decreased Anal spasm
Decreased PR bleeding |
7th 15th & 21th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decreased Burning Pain in Ano
Decreased Anal spasm
Decreased PR bleeding |
7th 15th & 21th Day |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
06/06/2025 |
| 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
|
Ushir is very effective in Pitta and Daah shamak drug which reduces the burning sensation & also helps in relieving pain. Hence, concept of application of ushir in the form Malahar (Ushir Malahar) will be prepared, which can be used (self-applied) by patient locally USHIR Malahar has Vranaropaka, Dahashamaka properties. Malahar provides desired from and consistency to the ointment. It releases medicament easily at application site. It should not produce irritation and sensitization of skin. So there is need for an effective and short term therapy. Hence this study is attempted to evaluate the Vranaropaka and Dahashamak properties of USHIR Malahar.
100 patients were selected randomly and divided into 2 groups of 50 patients each one group will be prescribed sucralfate+Metronidazole +lignocain hydrochloride ointment and trial group will be prescribed Ushir Malhar Hence attempt is made to evaluate the efficacy of USHIR Malahar in management of Parikartika (acute fissure in ano).
|