| CTRI Number |
CTRI/2024/12/077876 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study The Effect Of Ashwagandhadi Malhar In The Management Of Parikartika |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial To Study The Efficacy Of Ashwagandahdi Malhar In The Management Of Parikartika With Special Refrence 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 Bipul Durgaprasad Jarare |
| Designation |
MS Scholar Shalyatantra Samanya |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashi |
| Address |
Department Of Shalyatantra Samanya Shree Saptashrungi Ayurved Mahavidyalaya And Hospital ,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
|
| Fax |
|
| Email |
bjarare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Raut |
| Designation |
H.O.D. |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Nashik |
| Address |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi,
Panchavati, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
9822979769 |
| Fax |
|
| Email |
dr.aparnaraut12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bipul Durgaprasad Jarare |
| Designation |
MS Scholar Shalyatantra Samanya |
| Affiliation |
Shree Saptashrungi Ayurved Mahavidyalaya,Nashik |
| Address |
Department Of Shalyatantra Samanya Shree Saptashrungi Ayurved Mahavidyalaya And Hospital ,Kamal nagar Hiravadi, Panchavati, Nashik, Maharashtra 422003
Nashik
MAHARASHTRA
422003
India |
| Phone |
8928951726 |
| Fax |
|
| Email |
bjarare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Saptashrungi Ayurved Medical College And Hospital , KamalNagar , Hirawadi , Panchwati,Nashik Maharashtra 441107 |
|
|
Primary Sponsor
|
| Name |
Shree Saptashrungi Ayurved Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik |
| Address |
Department of Shalyatantra Samanya, Shree Saptashrungi Ayurved
Mahavidyalaya,Kamal nagar Hiravadi, Panchavati, Nashik,
Maharashtra 422003 |
| 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 Bipul Durgaprasad Jarare |
Shree SaptashAyurved Medical College And Hospital |
Department Of Shalyatantra Samanya Shree Saptashrungi Ayurved Medical College And Hospital,
KamalNagar, Hirawadi
, Panchawati, Nashik 422003
Nashik MAHARASHTRA
Nashik
MAHARASHTRA |
08928951726
bjarare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Shree Saptashrungi Ayurved Mahavidyalaya Nashik |
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: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandadi malhar, Reference: Bhaishyajya Ratnavali 47/44, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatdhaut Ghrut , Reference: Bruhat Nighantu Ratnakar 1325, Route: Topical, Dosage Form: Ghrita, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients having symptoms of parikartik (kartanvatvedana,daha,raktastrava,kandu)
2)Patients irrespective of sex, religion, occupation & economic status.
3)Patients between the age group of 18 to 60 years.
4)Patients which agreed for treatment with written consent. |
|
| ExclusionCriteria |
| Details |
1)Age less than 18 years and more than 60 years. 2)Patients having Parikartika (Fissure-in-ano) secondary to Ulcerativecolitis, Syphilis, crohn’s disease, Tuberculosis and Ca of rectumand anal
canal.
3)Patients with infectious diseases like HIV/HbsAg/HCV.
4) Patient having HB percentage less than 7
5)Patient with uncontrolled Diabetes and Hypertension.
6)Patients associated with conditions like Hemorrhoids (Arsha), Fistulain-ano (Bhagandar).
7) Patients with Perianal abscess, rectal prolapsed and severe local sepsis
8)Immunocompromised patient
9)Any previous anal surgery.
10)Not willing to give consent. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduce The Sign And Symptoms of Fissure In Ano. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Reduce The Reccurency Of Fissure In Ano |
21 Days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/12/2024 |
| Date of Study Completion (India) |
16/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective
1.Primary Objective To study the efficacy of ashwagandhadi malahar in Parikartika with special Reference to Fssure In Ano in comparision with shatdhout ghrut. 2.SecondaryObjective
1.To study Parikartika in details as per Ayurvedic concept. 2.To study Fssure In Ano in details according to modern aspect. 3.To study the effect of trial drug i.e ashwangandhadi malahar and Shatdhautghrut.
PARTICIPANTS 120 Adults diagnosed with fissure in ano meeting inclusion and exclusion criteria from OPD and IPD of department of shalyatantra of Shree Saptashrungi Medical College and Hospital Nashik Interventions 60 patients ashwagandhadi malahar: Administered according to standardized protocol. 60 patients shatdhout ghrut. : Administered according to standardized protocol. Primary Outcome : Reduce the sign and symptoms of fissure in ano Secondary Outcome: No recurrency of fissure in ano Treatment Duration : 7Days Follow Up :3rd , 5th , 7th Days Data Analysis : Data will be analysed using appropriate statistical methods to compare the effectiveness of the intervension on the primary and secondary outcomes. Ethical Considerations : The study will be conducted in accordence with ethical guidelines and with informed consent from participents. |