| CTRI Number |
CTRI/2022/03/041506 [Registered on: 30/03/2022] Trial Registered Prospectively |
| Last Modified On: |
26/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Management of Bleeding piles without surgery |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON KUTAJADI CHURNA AND YAVANYADI CHURNA IN THE MANAGEMENT OF RAKTARSHA W.S.R. 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 SEVANT KUMAR SAHU |
| Designation |
PG SCHOLAR |
| Affiliation |
NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA |
| Address |
OPD no. 15 DEPT. OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA
DEPT. OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA
Raipur
CHHATTISGARH
492001
India |
| Phone |
9098286148 |
| Fax |
|
| Email |
Sevantsahu@Gmail.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
DrBalendra Singh |
| Designation |
Proffesor and HOD |
| Affiliation |
NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA |
| Address |
OPD NO.15 DEPT. OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA
DEPT. OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA
Raipur
CHHATTISGARH
492001
India |
| Phone |
9039180335 |
| Fax |
|
| Email |
drbalendrasingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Avinash markam |
| Designation |
Lecturer shalya tantra |
| Affiliation |
NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA |
| Address |
DEPT. OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA
DEPT. OF SHALYA TANTRA SHREE NARAYAN PRASAD AWASTHI GOVERNMENT AYURVEDA COLLAGE RAIPUR CHATTISGARH 492001 INDIA
Raipur
CHHATTISGARH
492001
India |
| Phone |
9098286148 |
| Fax |
|
| Email |
avi.kavi06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri narayan prasasd awasthi govt.ayurveda collage raipur chattisgarh |
|
|
Primary Sponsor
|
| Name |
Shri Narayan Prasad Awasthi Govt Ayurved Collage Raipur Chattisgarh India |
| Address |
Dept.Of Shalya Tantra Shri Narayan Prasad Awasthi Govt. Ayurved Collage Raipur Chattisgarh India |
| Type of Sponsor |
Other [Shri Narayan Prasad Awasthi Govt. Ayurved Collage Raipur Chattisgarh India] |
|
|
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 sevant kumar sahu |
Shri khudadad doonga ji govt. ayurveda hospital Raipur |
opd num 15 department of shalya tantra govt.ayurveda hospital Raipur Chattisgarh
Raipur
CHHATTISGARH |
9098286148
SEVANTSAHU@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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Kutajadi Churna, Reference: Astanga Hridaya chikitasa Sthan 8/103, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ushnodak), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Yavanyadi Churna, Reference: Astanga Hridaya ChikitsaSthan 8/115, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Ushnodak), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age Group Between 18 Years To 60 years
Sex both Male & female
1st & 2nd Degree Raktarsha
The patient who Presented with the Signs and
Symptom of Raktarsha |
|
| ExclusionCriteria |
| Details |
Age below 18 year and above 60 year
pregnancy
Lactating mother
Hiv ,HBsAG
Patient with malignancy
Congenital diseas of rectumand anal canal
pile mass of 3rd and 4th degree |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| management of Bleeding due to Bleeding piles by Medicinal Treatment |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Permanent stoppage of bleeding and cure of bleeding piles |
28 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/04/2022 |
| Date of Study Completion (India) |
15/01/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
17/02/2023 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nill |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
1. Mostly modern physician advice surgery in Hemorrhoids but in Ayurveda has the better option for conservative management because there is no side effects if it is taken proper as advised and no hospitalization required. 2 So many research work have done in Raktarsha but no previous work of Comparative study in the Kutajadi churna and Yavanyadi churna in the management of Raktarsha. 3 They can use safely on the patient who is afraid of surgery. 4 The incidence of hemorrhoids apparently increases with age and it seems likely to about 50% of people have some degree of hemorrhoids over the age of fifty. 5 Kutajadi churna and Yavanyadi churna are having ingredients with Deepana, Pachana, Raktastambhana, Vatanulomana, Vednahara, and Arsha nashaka properties which cures â… st & â…¡ nd degree hemorrhoids Rapidly. 6 Both drugs are very cost effective and cheap, so all types of patients easily effort the treatment |