| CTRI Number |
CTRI/2022/05/042470 [Registered on: 11/05/2022] Trial Registered Prospectively |
| Last Modified On: |
06/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Parikartika(Fissure in Ano) |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE EFFICACY OF RAKTACHANDAN MALHAR(LOCALLY)ALONG WITH HARITAKI CHURNA VATI (INTERNALLY) IN THE MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE IN ANO. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shivraj Dnyaneshwar Navale |
| Designation |
PG Scholar |
| Affiliation |
Dr. D.Y Patil School of Ayurveda, Navi Mumbai |
| Address |
Dr DY Patil School of Ayurveda, sec 7, Department of Shalyatantra, opd No3 1st floor Nerul Navi Mumbai.
Dr DY Patil School of Ayurveda, sec 7, Department of Shalyatantra, opd No3 1st floor Nerul Navi Mumbai.
Thane
MAHARASHTRA
40706
India |
| Phone |
9834636348 |
| Fax |
|
| Email |
navaleshivraj3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amarprakash Dwivedi |
| Designation |
Professor |
| Affiliation |
Dr. D.Y Patil School of Ayurveda, Navi Mumbai |
| Address |
Department of Shaya Tantra, School of Ayurveda, D.Y Patil deemed to be university, Nerul, Navi Mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9323097013 |
| Fax |
|
| Email |
amar.dwivedi@dypatil.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amarprakash Dwivedi |
| Designation |
Professor |
| Affiliation |
Dr. D.Y Patil School of Ayurveda, Navi Mumbai |
| Address |
Department of Shaya Tantra, School of Ayurveda, D.Y Patil deemed to be university, Nerul, Navi Mumbai
MAHARASHTRA
400706
India |
| Phone |
9323097013 |
| Fax |
|
| Email |
amar.dwivedi@dypatil.edu |
|
|
Source of Monetary or Material Support
|
| D.Y Patil School of Ayurveda and Hospital, DY Patil Vidyanagar, Sec 7, Nerul, 400706 |
|
|
Primary Sponsor
|
| Name |
Dr Shivraj Dnyaneshwar Navale |
| Address |
Dr DY Patil School of Ayurveda, Department of Shalyatantra,Nerul Navi Mumbai. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr SHIVRAJ DNYANESHWAR NAVALE |
D.Y PATIL DEEMED TO BE UNIVERSITY, SCHOOL OF AYURVEDA, NERUL NAVI MUMBAI. |
D.Y PATIL DEEMED TO BE UNIVERSITY, SCHOOL OF AYURVEDA, DEPARTMENT OF SHALYATANTRA, OPD NO 3. 1ST FLOOR SEC7 NERUL NAVI MUMBAI
Thane
MAHARASHTRA |
9834636348
shivrajnavale3@gmail.com |
| Dr Shivraj Dnyaneshwar Navale |
DY Patil School of Ayurveda |
DYPatil School of Ayurveda and Hospital DY Patil Vidyanagar Sec 7 Nerul 400706
Thane
MAHARASHTRA |
9834636348
navaleshivraj3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BORS |
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 | - | | | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Raktachandan malhar, Reference: bhaisajya kalpana, Route: Rectal, Dosage Form: Malahara/ Ointment/ Balm, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: No, Additional Information: local application of raktachandan malhar with help of applicator(twice daily) |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed Patients of Acute fissure in ano (Onset upto 28 days) without Sentinel Tag & Anal papillae
Patients among the age group 18 to 60 yrs irrespective of gender religion occupation educational status and socio-economic status
|
|
| ExclusionCriteria |
| Details |
Chronic Fissure in Ano (Onset more than 28 days) with Sentinel Tag & Anal papillae
Bleeding Disorder like Hemophilia etc Patient with uncontrolled systemic disease like diabetes and hypertension. Patient with Ca rectum.Patient having Parikartika secondary to Ulcerative colitis Syphilis Crohn’s disease, T.B. HIV Hepatitis etc
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evalute the effect of Raktachandan Malhar(locally) in the management of symptoms such as burning sensation pain anal spincter spasm ulcer and bleeding P/R |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/05/2022 |
| Date of Study Completion (India) |
15/02/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
TITLE
"A CLINICAL STUDY TO
EVALUATE THE EFFICACY OF RAKTACHANDAN MALHAR (LOCALLY) ALONG WITH HARITAKI
CHURNA VATI (INTERNALLY) IN THE MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE IN
ANO" AIM AND OBJECTIVES AIM:
TO STUDY THE
CLINICAL EFFICACY OF RAKTACHANDAN MALHAR(LOCALLY) ALONG WITH HARITAKI CHURNA
VATI (INTERNALLY) IN THE MANAGEMENT OF PARIKARTIKA W.S.R. TO FISSURE IN ANO.
OBJECTIVES:
Primary:
•
To evaluate the effect of
Raktachandan Malhar (Locally) in the management of symptoms such as
Burning sensation, Pain, Anal sphincter Spasm, Ulcer and Bleeding P/R.
•
To establish Raktachandan
Malhar as local (user friendly), cost effective treatment for Parikartika
w.s.r. to fissure in ano.
•
To review the Ayurvedic
and Modern literature in context to Parikartika and Fissure in Ano and
advancement in its management. RESEARCH
QUESTION: - •
Is Raktachandana Malhar (Locally) along
with Haritaki churna Vati (Internally) effective in the management of
Parikartika w.s.r. to fissure in ano? Hypothesis: - Null Hypothesis: - •
Raktachandana Malhar
(Locally) along with Haritaki churna Vati (Internally)
is not effective in the management of Parikartika w.s.r. to fissure in ano. Alternate Hypothesis: -
•
Raktachandana Malhar (Locally) along with
Haritaki churna Vati (Internally) is effective in the management of
Parikartika w.s.r. to fissure in ano. Method of preparation of Raktachandan malhar Raktachandana kwath
were prepared as per authentic procedures of preparation. The coarse powder of
Raktachandan stored in a vessel and soaked with water then boiled with 16 times
of water until it reduces to a quarter. Then Tila
Taila was taken in a suitable pot heated on the flame till bubbles rise off.
Tila Taila Murchhana was done and allowed it to cool by itself Then 1 part of kwath
was added into 1 part of Tila Taila and mandagni till khara paak awashta was
achieved. Then taila was sieved, collected in clean and sterile container. Malhar nirman vidhi Some Base material is required for
preparation of Malhar and Siktha (Bee Wax) is one among them. So, we are using
siktha as a base to prepare Raktachandan Taila Malhar. Malhar nirman vidhi: Ratio of Siktha to taila is taken as
1:5 respectively. As there is no direct reference of
preparation of Raktachandan Taila Malhar, it was prepared by common method of
preparation of Malhar kalpana explained in Rasatarangini. 1 part of bee wax
(siktha) is added to the 5 parts of RaktachandanTaila. After heating the taila, the bee
wax was added and stirred well. After complete melting of bee wax, flame was
switched off and continuous stirring of mixture was done till the final product
(Malhar) is obtained. It was stored in container and was observed till it
attained semi-solid consistency. PREPARATION OF HARITAKI CHURNA VATI
Raw dried fruit of Haritaki was
taken and its seeds was removed. Process the powder of haritaki. Pills
measuring 500mg each was prepared from the powder.
|