| CTRI Number |
CTRI/2024/11/076791 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Bhallatakadi Modaka in the management of Piles |
|
Scientific Title of Study
|
Effect of Bhallatakadi Modaka in the management of Raktarsha- A randomized clinical trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarojani Kuchanur |
| Designation |
PhD Scholar |
| Affiliation |
SGT University |
| Address |
Shalya Tantra Dept, FIMS SGT University, Gurgaon
Gurgaon
HARYANA
122492
India |
| Phone |
7011940769 |
| Fax |
|
| Email |
sarojanish@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Avnish Pathak |
| Designation |
Professor and HOD |
| Affiliation |
SGT University |
| Address |
Shalya Tantra Dept, FIMS,SGT University
Gurgaon
HARYANA
122492
India |
| Phone |
9886593705 |
| Fax |
|
| Email |
avnish_fims@sgtuniversity.org |
|
Details of Contact Person
Public Query
|
| Name |
Sarojani Kuchanur |
| Designation |
PhD Scholar |
| Affiliation |
SGT University |
| Address |
Shalya Tantra Dept, FIMS SGT University, Gurgaon
Gurgaon
HARYANA
122492
India |
| Phone |
7011940769 |
| Fax |
|
| Email |
sarojanish@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarojani Kuchanur 7011940769 Shalya Tantra Dept SGT University Gurgaon Haryana 122505
Shalya Tantra OPD, SGT University Gurgaon, 7011940769. Haryana 122505
|
|
|
Primary Sponsor
|
| Name |
Sarojani Kuchanur |
| Address |
Shalya Tantra Dept SGT University Gurgaon Haryana, India Pin-122505 |
| 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 |
| Sarojani Kuchanur |
G.S Ayurveda medical College |
OPD No- 13 , Shalya OPD
G.S Ayurveda medical College, Pilkhuva
Meerut
UTTAR PRADESH |
7011940769
sarojanish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC G.S AMC&H |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K640||First 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: Bhallataka Modaka, Reference: Arsorogadhikara,Bhaisajyaratnavali, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: Buttermilk), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Bolabadha Rasa, Reference: Ayurveda Sara Samgraha, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2(g), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: -Buttermilk), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex between 20-60 years of age group with 1st and 2nd-degree Haemorrhoids |
|
| ExclusionCriteria |
| Details |
Thrombosed Haemorrhoids, Prolapsed Haemorrhoids.
Haemorrhoids with other entities like Fissure in Ano, and Fistula in Ano.
History of Systemic Illnesses like HTN, DM, Peptic ulcer, Inflammatory Bowel Diseases, HIV I & II, HBsAg reactive
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decline in the Bleeding PR from baseline to 8 days from Baseline |
8 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/11/2024 |
| Date of Study Completion (India) |
30/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [sarojanish@gmail.com].
- For how long will this data be available start date provided 02-01-2025 and end date provided 01-01-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
RESEARCH QUESTION: Is there any effect of Bhallataka Modaka in reducing
bleeding in patients of Raktarsha compared to Bolabaddha rasa? Groups: Two Group A – Bhallatakadi
Modaka as Internal Medicine – 2gms/day Group B
– Bolabadda Rasa as Internal Medicine – 2gms/day Selection
of Cases: - Raktarsha w.s.r to 1st and 2nd degree Haemorrhoids Inclusion
Criteria: Patients
of either sex between 20-60 years of age group with 1st and 2nd degree
Haemorrhoids. Exclusion
Criteria • Thrombosed
Haemorrhoids, Prolapsed Haemorrhoids. • Haemorrhoids
with other entities like Fissure in Ano, and Fistula in Ano. • History
of Systemic Illnesses like HTN, DM, Peptic ulcer, Inflammatory Bowel Diseases,
HIV I & II, HBsAg reactive Assessment
Criteria The
following criteria will be used: 1. Bleeding
during defaecation 2. Pain
in relation to defecation 3. Constipation 4. Protrusion
of pile mass 5. Mucus
discharge 6. Itching
at anus Expected
Outcome: Decline in the Bleeding PR from baseline to 8 days from
Baseline
|