| CTRI Number |
CTRI/2024/11/077081 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Shwet Malahar against Shatadhaut ghrita for local application in the management of parikartika. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Trial to evaluate the efficacy of Shwet Malahar against Shatadhaut ghrita for local application in the management of parikartika. |
| 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 Vaishnavi Rajan More |
| Designation |
Pg Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third floor,Shalyatantra department Sector no.25, Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
8329976716 |
| Fax |
|
| Email |
vaishnavirajanmore@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran,Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhavi Banarase |
| Designation |
Professor and H.O.D |
| Affiliation |
PDEAs College of Ayurved and Research Centre,Nigdi,Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Nigdi Pradhikaran,Pune
MAHARASHTRA
411044
India |
| Phone |
9423207569 |
| Fax |
|
| Email |
dr.madhavibanarase209@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre, Nigdi, Pune 411044, Maharashtra, India. |
|
|
Primary Sponsor
|
| Name |
PDEAs College of Ayurved and Research Centre, Nigdi Pune |
| Address |
PDEAs College of Ayurved and Research Centre,Third
floor, Shalyatantra department Sector no.25, Nigdi Pradhikaran,Pune |
| 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 vaishnavi Rajan More |
Ayurved Rugnalya and Sterling Multi-speciality Hospital, Nigdi Pune |
Ayurved Rugnalaya and
Sterling Multi-speciality
Hospital, Shalyatantra
Department, OPD No
123A Pradhikaran Nigdi Pune
Pune
MAHARASHTRA |
8329976716
vaishnavirajanmore@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shatadhaut ghrita , Reference: Sushrut Sanhita Uttartantra, Route: Topical, Dosage Form: Ghrita, Dose: 2(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: No, Route: -, Dosage Form: Ghrita, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Shwet Malahar, Reference: Siddhayogsangraha Vrana-adhikar, Route: Topical, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 15 Days, Reference: No, Route: NA, 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.Patients having anal spasm, sentinel tag and visible fissure during P/R examination will be included.
2.Patients irrespective of gender, religion, occupation, economical and marital status will be selected.
|
|
| ExclusionCriteria |
| Details |
1.Patients having Parikartika (Fissure-in-Ano) secondary to Ulcerative colitis, Chron’s Disease
2.Known case of - Syphilis, Tuberculosis, Uncontrolled Diabetes, and Carcinoma of rectum.
|
|
|
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 |
| The effect of Shwet Malahar will be accessed with the effect of Shatadhaut Ghrita for local application in parikartika assessment will be done by criteria like P/R Bleeding, Burning Sensation, Constipation, Parikartanvat vedana , Anal Spasm, Wound Healing. |
Patient will be followed up on 5th, 10th, 15th, and then 21st. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/12/2024 |
| 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
|
Now a day due to faulty lifestyle or irregularity in diet and diet timing and also sedentary lifestyle. In addition to change in diet and lifestyle, one is always under tremendous mental stress. All these causes disturb in digestive system which results in too many diseases amongst them anorectal disorder constitute an important group. On the basis of the clinical symptom the diseases fissure-in-ano has been classified into two verities; viz. acute fissure-in-ano and chronic fissure-in-ano. Either acute or chronic pain, bleeding, burning sensation is the main symptom of this condition. Pain is sometimes intolerable. In long standing cases it may be associated with hemorrhoids or a sentinel tag. Pruritus ani may be another symptom of this condition. On the basis of symptoms, the disease fissure-in-ano can be compared to the disease Parikartika according to Ayurveda, Parikarta / Fissure-in-ano is very common and painful condition. Acharya Sushrut has described the term Parikartika. Aacharya Charak has also mentioned Parikartika as complication of vamana and virechana. Rationale of the study - There are some local applications are available in market, but they act as lubricant, give temporary relief from pain, they have no role in fissure healing. Shatadhaut Ghrita plays a role in local lubrication, relief pain and the heals the ulcer also, but the procedure of its preparation is difficult and time consuming. Also in 100 washes its quantity gets reduces, which increases the cost. In market Shatadhaut Ghrita is available, as it is prepared for commercial purposes there is doubt as it is prepared as giving 100 washes. The aim is to prepare simple remedy which is easy to apply, cost effective and gives local lubrication, relives pain and heals the ulcer. Thus, in this study, the attempt is being made to observe the effect of "Shwet Malahar" in treatment of Parikartika. Moreover, there has been no work carried out on topical management of Parikartika with "Shwet Malahar". Hence, an attempt is being made to see the effect of "Shwet Malahar" instead of any surgical intervention.
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