| CTRI Number |
CTRI/2025/08/092531 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparison Between Two Ayurvedic Lepa Ashwagandhadi Lepa and Jatyadi Ghrita Lepa for Treating Fissure in ano. |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Ashwagandhadi Lepa And Jatyadi Ghrita Lepa In The 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 Arpit Surya |
| Designation |
PG Scholar |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital And Research Centre |
| Address |
Department Of Shalya Tantra In PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2, Ramagondanahalli, Yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9418101023 |
| Fax |
|
| Email |
suryaarpit07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Srinivasa D H |
| Designation |
Professor |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital And Research Centre |
| Address |
Department Of Shalya Tantra In PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2, Ramagondanahalli Yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9845546319 |
| Fax |
|
| Email |
ayursrini@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramya R |
| Designation |
Professor |
| Affiliation |
Ramakrishna Ayurvedic Medical College, Hospital And Research Centre |
| Address |
Department Of Shalya Tantra In PG Studies, Ramakrishna Ayurvedic Medical College, Hospital And Research Centre, 54/2, Ramagondanahalli Yelahanka, Bangalore.
Bangalore
KARNATAKA
560064
India |
| Phone |
9964278207 |
| Fax |
|
| Email |
drramyar28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ramakrishna Ayurvedic Medical College Hospital And Research Centre 54/2 , Ramagondanahalli, Yelahanka,Bangalore, 560064. |
|
|
Primary Sponsor
|
| Name |
Dr Arpit Surya |
| Address |
Ramakrishna Ayurvedic Medical College Hospital And Research Centre 54/2 , Ramagondanahalli, Yelahanka, Bangalore, 560064. |
| 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 Arpit Surya |
Ramakrishna Ayurvedic Medical College Hospital And Research Centre |
Department Of Shalya Tantra In PG Studies,Ramakrishna Ayurvedic Medical College Hospital And Research Centre 54/2 , Ramagondanahalli, Yelahanka,Bangalore, 560064.
Bangalore
KARNATAKA |
9418101023
suryaarpit07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ramakrishna Ayurvedic Medical College Hospital And Research Centre Ethical Clearance Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K600||Acute anal fissure. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Ashwagandhadi Lepa, Reference: Bhaishajya Ratnavali, Ch- 47 VranaShothadhikar,Shloka - 44, Route: Topical, Dosage Form: Kalka/ Paste , Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Jatyadi Ghrita, Reference: Ashtang Hridayam, Uttar Tantra, Ch-25 Vrana Pratishedha Adhyaay, Shloka - 67, Route: Topical, Dosage Form: Ghrita, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 15 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 presenting with the complaints of Acute Fissure-in-ano like
constipation, painful and burning defecation and bleeding per rectum (Streaks/
Drops).
2. Age group 18-60 years.
3. Patient will be selected Irrespective of sex, religion, occupation, and economic
status. |
|
| ExclusionCriteria |
| Details |
1. Fissure secondary to Ulcerative colitis, Tuberculosis, Syphilis, Crohn’s
disease, inflammatory bowel disease.
2. Carcinoma of rectum, carcinoma of anus, Fistula in ano and Hemorrhoids.
3. Reactive to HbsAg, Anti HCV, HIV and other immunosuppressed diseases.
4. With other systemic disorder like uncontrolled hypertension, uncontrolled diabetes
mellitus.
5. Impaired cardiac, renal and hepatic function.
6. Patient Diagnosed with Chronic Fissure In Ano |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing Of Fissure, Reduction In Pain, Reduced Bleeding |
0th day , 5th day , 10th day , 15th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
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)
|
19/08/2025 |
| 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="2"
Months="0"
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
|
This is a postgraduate academic clinical study conducted to compare the Therapeutic Efficacy of Ashwagandhadi Lepa and Jatyadi Ghrita Lepa in the management of Parikartika with special reference to Acute fissure-in-ano. Parikartika is a condition in which there is a formation of ulcer in lower anal region along with cutting pain and burning sensation.
In this study two Classical Ayurvedic Formulations are being compared in efficacy for the treatment of Parikartika. The Formulations being Ashwagandhadi Lepa and Jatyadi Ghrita. The primary objective of the study is to assess and compare the reduction in pain, burning sensation and healing of ulcer in acute case of fissure in ano.
Here Participants will be allocated randomly in two groups. The treatment will be given for 15 days followed by a follow up of once in 15 days for 1 month after the study duration.
The outcome of this study will help to evaluate the comparative efficacy of the above two mentioned drugs, in the management of parikartika / Acute fissure In Ano. |