| CTRI Number |
CTRI/2024/03/064339 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Mahanimb beej churna in Bleeding piles. |
|
Scientific Title of Study
|
Randomized open controlled clinical study to evaluate the efficacy of Mahanimb beej churna in Raktarsha with special reference to Bleeding piles |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Kumar Pandey |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD No 4
Shalya Tantra Department Yashwant Ayurvedic College post graduate and Research institute
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9140648940 |
| Fax |
|
| Email |
ajay.pandey51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narhare Laxmi Maroti |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD No 4
Shalya Tantra Department Yashwant Ayurvedic College post graduate and Research institute, Kodoli, Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9822189226 |
| Fax |
|
| Email |
drlaxminarhare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Pandey |
| Designation |
PG Scholar |
| Affiliation |
Yashwant Ayurvedic College PGT and RC Kodoli |
| Address |
OPD No 4
Shalya Tantra Department Yashwant Ayurvedic College post graduate and Research institute, Kodoli, Kolhapur
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
9140648940 |
| Fax |
|
| Email |
ajay.pandey51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yashwant Ayurvedic College PGT and RC Kodoli |
|
|
Primary Sponsor
|
| Name |
Dr Ajay Kumar Pandey |
| Address |
Yashwant Ayurvedic College PGT and RC
Kodoli
Shalyatantra Department OPD No 4Yashwant Ayurvedic College PGT and RC
Kodoli
Kolhapur 416114
|
| 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 Ajay Kumar Pandey |
Yashwant Ayurvedic College PGT and RC Kodoli |
Yashwant Ayurvedic College PGT and RC
Kodoli
Shalyatantra Department OPD No 4
Kolhapur
MAHARASHTRA |
9140648940
ajay.pandey51@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K641||Second degree hemorrhoids. Ayurveda Condition: RAKTAJA-ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahanimb Beej Churna, Reference: Brihat Nighantu Ratnakar Raktarsha Chikitsa Page no 1740, Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Samanya Jal), Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Tab Annocare , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 15 Days, anupAna/sahapAna: Yes(details: -Samanya Jal), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1) Irrespective of Gender
2) Patient’s having Clinical feature of Raktarsha
3) Patients with Duration of Complaints less than 6 months.
4) Patient with I degree and II degree bleeding piles.
5) Patient with Hb more than 10gm% in male and more than 8gm% In female.
6) Pile mass palpated or seen by per rectal examination |
|
| ExclusionCriteria |
| Details |
1. Patients with III degree and IV degree bleeding piles.
2. Piles associated with Perianal abcess, fissure, fistula.
3. Rectal Prolapse, Rectal polyp
Known case of Ulcerative Colitis, CA Rectum, HIV, HbsAg, tuberculosis.
4. Piles with Complications as Infected, Thrombosed
5. Patients with associated systemic Disorders.(DM, heamophillic disease )
6. Pregnant and lactating mother |
|
|
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 |
| To study the efficacy of Mahanimb Beej Churn in Raktarsha w.s.r. to bleeding piles. |
Baseline
5th day
10th day
15th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study the literature of Mahanimb Beej Churn regarding raktarsha
w.s.r. to bleeding piles.
To study the efficacy of Mahanimb beej churna on the sign symptoms of raktarsh .
To study the arsh vyadhi in classical and modern science
To achieved the outcome of study in 15 days .
observe the adverse effect if any. |
Baseline
5th day
10th day
15th day |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/03/2024 |
| 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="6"
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 study is Randomized open Controlled clinical study to evaluate the efficacy of Mahanimb beej churna in Raktarsha with special reference to Bleeding Piles. Study will be carried in OPD of Shalyatantra department of Yashwant Ayurvedic College PGT and RC Kodoli . The observation would be drawn on the basis of symptoms after treatment given. |