| CTRI Number |
CTRI/2024/09/074129 [Registered on: 20/09/2024] Trial Registered Prospectively |
| Last Modified On: |
04/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effective Management Of Anal Fissure Through Ashwagandhadi Lepa |
|
Scientific Title of Study
|
A Randomised Controlled Trial To Evaluate The Effect Of Ashwagandhadi Lepa In The Management Of Parikartika (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 Ravendra Kumar Tiwari |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and hospital chennai ,Tamilnadu |
| Address |
Department of Shalya Tantra, Room no.8,OPD block Sri Jayendra Saraswathi Ayurveda college and hospital Nazarathpet,Chennai,Tamilnadu
Thiruvallur TAMIL NADU 600123 India |
| Phone |
9009144999 |
| Fax |
|
| Email |
drrktiwari2022@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr T Udayakiran |
| Designation |
Professor and HOD, Department of PG studies in shalya Tantra |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and hospital chennai ,Tamilnadu |
| Address |
Department of Shalya Tantra, Room no.8,OPD block Sri Jayendra Saraswathi Ayurveda college and hospital Nazarathpet,Chennai,Tamilnadu
Thiruvallur TAMIL NADU 600123 India |
| Phone |
9849666054 |
| Fax |
|
| Email |
dr_tenneti@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Ravendra Kumar Tiwari |
| Designation |
Post Graduate Scholar |
| Affiliation |
Sri Jayendra Saraswathi Ayurveda College and hospital chennai ,Tamilnadu |
| Address |
Department of Shalya Tantra, Room no.8,OPD block Sri Jayendra Saraswathi Ayurveda college and hospital Nazarathpet,Chennai,Tamilnadu
Thiruvallur TAMIL NADU 600123 India |
| Phone |
9009144999 |
| Fax |
|
| Email |
drrktiwari2022@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayendra Saraswathi Ayurveda College And Hospital Nazarathpet ,Chennai,Tamilnadu Pin-600123 |
|
|
Primary Sponsor
|
| Name |
Dr Ravendra Kumar Tiwari |
| Address |
Sri Jayendra Saraswathi Ayurveda College And Hospital Nazarathpet ,Chennai,Tamilnadu Pin-600123 |
| 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 Ravendra Kumar Tiwari |
Sri Jayendra Saraswathi Ayurveda College And Hospital Chennai |
Department Of Shalya Tantra ,Room No.8,OPD Block, Sri Jayendra Saraswathi Ayurveda College Hospital Chennai Thiruvallur TAMIL NADU |
9009144999
drrktiwari2022@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Sri Jayendra Saraswathi Ayurveda College and Hospital,Department of Ayurveda SCSVMV,Nazarathpet,Chennai-600123 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: PARIKARTIKA, (2) ICD-10 Condition:K602||Anal fissure, unspecified. Ayurveda Condition: PARIKARTIKA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,Vanagasen Chikitsa Sarasamgraha Vol.2 Chapter 54 Vrana Shotha Chikitsa, Procedure details: The patient will be taken to lie down in the lithotomy position, inspection and palpation will be done. Digital examination will be done and anal region will be cleaned with an antiseptic solution and the required quantity of Ashwagandhadi lepa wiil be taken and apply digitally or through an applicator. the dressing will be done after the application of the lepa. ) (1) Medicine Name: Ashwagandhadi Lepa, Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,Vanagasen Chikitsa Sarasamgraha Vol.2 Chapter 54 Vrana Shotha Chikitsa, Route: Topical, Dosage Form: Lepa Churna, Dose: 2(g), Frequency: od, Duration: 15 Days | | 2 | Comparator Arm | Procedure | - | lepa, लेप | (Procedure Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,, Procedure details: The patient will be taken to lie down in the lithotomy position, inspection and palpation will be done. The digital examination will be done and the anal region will be cleaned with an antiseptic solution and the required quantity of Jatyadi Ghrita wiil be taken and applied digitally or through an applicator. the dressing will be done after the application of the lepa. )) (1) Medicine Name: Jatyadi Ghrita, Reference: Bhaishajya Ratnavali Chapter 47 Vrana Sotha Chikitsa Prakranam,, Route: Topical, Dosage Form: Ghrita, Dose: 2(g), Frequency: od, Duration: 15 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects diagnosed with the clinical sign and symptoms of Parikartika. |
|
| ExclusionCriteria |
| Details |
Known cases of inflammatory bowel diseases, Severe anal stenosis, Patients diagnosed with malignancy, Patients diagnosed with AIDS, Hepatitis B |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete healing of the parikartika vrana (Fissure wound) |
15 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complete healing of the Fissure wound without any complications. |
After completion of the study and wound healing (vrana), patients will be advised to follow up in 30 and 45 days. |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
23/09/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
One of the most prevalent anorectal diseases, Fissure in ano, is caused by a longitudinal tear in the anoderm beneath the dentate line. In this condition defecation is painful, and there is a streak of bleeding on the stool. It affects both males and females equally and is common in all age groups. Most of the fissures heal by conservative means but a significant proportion turn chronic, negatively impacting a patient’s overall quality of life. It has been reported that the yearly incidence is 1.1 per 1000 persons, which translates to a 7.8% lifetime risk1. Most patients with fissures are middle-aged or younger, with a mean onset of 39.9 years2. Anal fissure incidence is seen to be rather high in Chennai due to the hot climate and a diversified diet. According to studies done at the Government Medical College Tirunelveli Tamil Nadu on patients with anorectal diseases who were chosen at random, 30.7% had anal fissures3. The treatment options for chronic fissures are generally based on reducing the anal pressures and include non-surgical and surgical modalities. Out of the various treatment modalities available, need for a simple, cost-effective, non-invasive treatment should be adopted which goes with day to day life of the patient. In the conventional method to reduce pain, such as a sitz bath, topical anesthetics, steroids, and analgesics are used as supporting measures. Surgical treatments such as Lords Anal dilatations, posterior sphincterotomy5, fissurotomy6, lateral internal sphincterotomy 7, excision of the anal canal, and anal advancement of the flap8 often produce practical difficulties for the patient. External Applications such as Ropana taila, Pichu, Matra Basti, Varti, Ksharakarma, Kshara sutra and Lepa are explained. Ashwagandhadi Lepa is one of the such modality which has the property of healing the Vrana9. The main ingredients of Ashwagandhadi lepa are Ashwagandha, Katuki, Lodhra, Katphala, Madhuyashti, Manjistha & Flowers of Dhataki. Previous research work done by “Sikandan A, Shinomiya T, Nagahara Y(2018), Division of Life Science and Engineering, School of Science and Engineering, Tokyo Denki University, Hatoyama, Japan. Ashwagandha root extract exerts anti-inflammatory effects in HaCaT cells and regulating cytokines, International journal of molecular medicine.†This study reveals the anti-inflammatory activity of Ash-wex on the skin, by using the human keratinocyte cell line HaCaT. The result indicates that Ash-wex significantly works on anti-inflammation and ulcer healing10. Most of the ingredients of Ashwagandhadi lepam have anti-inflammatory, analgesic, and ulcer-healing properties. More over compared to modern modalities it is cost-effective, non-irritant, easily available, and convenient medicine. Goghritam has Madhur Rasa, Guru, Snigdha, Mridu Guna, Sheeta Veerya, VataPittaharam11, and Vrana Ropana properties12.So, There is the need to evaluate the effect of Ashwagandhadi Lepa with Ghrita (Trial Drug) and compare with Jatyadi Ghrita (as the standard of care) and as an external application in Fissure in Ano along with Triphala Churnam as a common laxative for both groups. |