| CTRI Number |
CTRI/2025/06/088965 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy between Nagkeshar choorna and Kutajtwak
vati in the management of Raktarsha given for 5 days on reducing rectal bleeding. (stream of blood) |
|
Scientific Title of Study
|
A Randomized Comparative clinical trial to evaluate the efficacy of
Nagkeshar Choorna with Kutajtwak Vati in the management of
Raktarsha.
|
| 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 Mohasin Makbool Mujawar |
| 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 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
8208061427 |
| Fax |
|
| Email |
mmujawar574@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate professor |
| 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 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharat K Oza |
| Designation |
Associate professor |
| 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 Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre,Third
floor,Shalyatantra department Sector no.25,Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
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,Pradhikaran, Nigdi
Pune
MAHARASHTRA
411044
India |
| 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 Mohasin Makbool Mujawar |
Ayurved Rugnalaya and Snowbell Multi-speciality Hospital, Nigdi Pune |
Ayurved Rugnalya
and Snowbell
Multi-speciality
Hospital,Shalyatantra
Department, OPD No
123A Pradhikaran
Nigdi Pune
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
8208061427
mmujawar574@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: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nagkeshar Choorna , Reference: Charak Chikitsastana 14/210, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Navneet,Sharkara), Additional Information: No any | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kutajtwak vati , Reference: Bhaishajya Ratnavali 9/172, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -Takra), Additional Information: -No any |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Raktarsha (Bleeding piles),Age between 20-60 yrs,Anaemia,Diabetes,Secondary piles |
|
| ExclusionCriteria |
| Details |
Major cardiac illness,
Associated with other anorectal conditions as follows
Fistula in ano,Prolapsed of the rectum,Perineal Abscess,Malignancy,Rectal polyp ,4
th degree haemorrhoids |
|
|
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 Nagkeshar choorna will be accessed with the effect of kutajtwak vati taken orally in Raktarsh.
Assessment will be done by criteria like gudagata shoola,gudgat raktstrav, gudkandu, gudstrav. |
Patient will be followed up on 1st,3rd and 6th day. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
30/06/2025 |
| 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="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
|
Haemorrhoids is one of the most common ano-rectal disease.Fast food,disturbed bowel habits,sedentary life style ,shift duties,stressful life,being obese,straining during bowel movemants,prolong standing & sitting these are the causes of Haemorrhoids. Haemorrhoids also called pile,these are dilated veins within the anal canal. Rationale of the study: Many patients tends towards surgical treatment instead this conservative treatment can be alternative. This attempt is made as a Poorvakarma of surgical treatment,as a preventive measure. There is a need to assess the comparision of Nagkeshar Choorna and Kutajtwak vati in the management of Raktarsha . Nagkeshar choorna is easily available and cheap as compared to other drugs. Hence, this is an attempt to provide a safe, effective and easily available remedy for Raktarsha.
|