| CTRI Number |
CTRI/2024/10/075554 [Registered on: 21/10/2024] Trial Registered Prospectively |
| Last Modified On: |
18/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To know the effect of kalyana kshara in the Treatment of Internal hemorrhoids |
|
Scientific Title of Study
|
Evaluation of efficacy of oral administration and local application of kalyana kshara on arshas wsr to internal hemorrhoids |
| 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 Raageshree R Mayur |
| Designation |
PG Scholar |
| Affiliation |
Dr BRKR govt Ayurveda and hospital |
| Address |
Opd Room No -6 Dept of Shalya tantra Dr BRKR Government Ayurvedic Medical college Erragadda Hyderabad Telangana 500038
Opd Room No-6 Dept of Shalya Tantra Dr BRKR Government Ayurvedic Medical college Erragadda Hyderabad Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
07892746685 |
| Fax |
|
| Email |
raageshreermayur98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Prabhakar |
| Designation |
Professor and HOD |
| Affiliation |
Dr BRKR govt Ayurveda and hospital |
| Address |
Opd Room No-6 Dept of shalya tantra Dr BRKR Government Ayurvedic Medical college Erragadda Hyderabad Telangana 500038
Opd Room No-6 Dept of shalya tantra Dr BRKR Government Ayurvedic Medical college Erragadda Hyderabad Telangana 500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8639224258 |
| Fax |
|
| Email |
drbpra9z@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Prabhakar |
| Designation |
PROFESSOR AND HOD |
| Affiliation |
Dr BRKR govt Ayurveda and hospital |
| Address |
Opd Room No-6 Dr BRKR Government Ayurvedic Medical college Erragadda Hyderabad Telangana 500038
Opd Room No-6 Dr BRKR Government Ayurvedic Medical college Erragadda Hyderabad Telangana,500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8639224258 |
| Fax |
|
| Email |
drbpra9z@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Brkr govt ayurvedic college and hospital Erragadda Hyderabad Telangana -500038 |
|
|
Primary Sponsor
|
| Name |
Dr Brkr govt ayurvedic college and hospital |
| Address |
Dr Brkr govt ayurvedic college and hospital ERRAGADDA Hyderabad 500038 |
| Type of Sponsor |
Government 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 Raageshree R Mayur |
Dr BRKR govt ayurvedic hospital |
Opd no 6 department of shalyatantra of Dr BRKR Govt ayurvedic medical college erragadda hyderabad telangana 500038
Hyderabad
TELANGANA |
7892746685
raageshreermayur98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of DR BRKR Government Ayurvedic College |
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: ARSAH, (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | pratisAraNam, पà¥à¤°à¤¤à¤¿à¤¸à¤¾à¤°à¤£à¤®à¥ | (Procedure Reference: Sushruta samhita Sutra sthana 11/18-21 , Procedure details: Application of Kalyana kshara over a pile mass once a day for 21 days )
(1) Medicine Name: Kalyana kshara, Reference: Sahasrayoga Churna prakarana bhasma ksharadi yoga IV/97 , Route: Topical, Dosage Form: Bhasma, Dose: 3(g), Frequency: od, Duration: 21 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: kalyana Kshara, Reference: Sahasrayoga churna prakarana Bhasma ksharadi yoga IV/97, Route: Oral, Dosage Form: Bhasma, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Pragbhakta, Duration: 21 Days, anupAna/sahapAna: Yes(details: Goghruta), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Internal hemorrhoids with and without bleeding.
2 Subacute Haemorrhoids
3 Interno-External hemorrhoids
4 Patients of age group 18- 60 years
5 Patient of either gender.
6 Patients who are willing to participate in the
study and who sign the Consent form.
|
|
| ExclusionCriteria |
| Details |
1 Rectal prolapse
2 Severe Acute thrombosed Haemorrhoids
3 Acute inflammation and infected condition.
4 Severe spasm of anal sphincter.
5 Malignant conditions
6 Portal hypertension, Liver Cirrhosis
7 HIV, HCV, HBsAg, VDRL - Positive patients
8 Patients with systemic diseases -
Eg- Uncontrolled Diabetes mellitus,
Uncontrolled Hypertension,
9 CCF,Cardiomegaly
10 Ulcerative colitis
11 Chron’s disease
12 Tuberculosis
13 Hemorrhoids from growth in Ano rectal area
(secondary hemorrhoids)
14 Haemophilia etc blood related disorders
15 Pregnancy, Lactating Mother
16 Severe malnutrition, Anaemia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in degree of hemorrhoids |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in quality of life |
21 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
29/10/2024 |
| 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="1"
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 is a randomized clinical trial on the Evaluation of efficacy of oral administration and local application of kalayana kshara on Arshas w.s.r. to Internal hemorrhoids in patients who will be clinically diagnosed and confirmed
cases of Internal hemorrhoids enlisted in inclusion criteria will be in single group of total 30 patients. They will be given Kalyana kshara orally as 500mg TID with anupana Go Ghruta for 21 days with local applicayion of kalayana kshara for 21 days follow up to 21 days in interval of 7 days . |