| CTRI Number |
CTRI/2024/05/067496 [Registered on: 16/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Pathyadi Kwath and Haridradi Lepa in Management Of Haemorrhoid |
|
Scientific Title of Study
|
A Clinical effect of Pathyadi Kwath and Haridradi Lepa in Arsha w.s.r. to Haemorrhoid |
| 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 Deepali Sundari Verma |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna
Patna
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepali Sundari Verma |
| Designation |
Professor |
| Affiliation |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna
BIHAR
800003
India |
| Phone |
9430471341 |
| Fax |
|
| Email |
drdeepali261996@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of Government Ayurvedic College and Hospital Kadamkuan Patna |
|
|
Primary Sponsor
|
| Name |
Government Ayurvedic College and Hospital Kadamkuan Patna |
| Address |
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna |
| 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 Priyanka Priya |
Government Ayurvedic College and Hospital Kadamkuan Patna |
Dept of Shalya tantra Government Ayurvedic College and Hospital Kadamkuan Patna
Patna
BIHAR |
8084814555
priyankakumari20235@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:K641||Second degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pathyadi Kwath, Reference: Bhishasjyaratnawali adhyay-9, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Antarabhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: -Apply Haridradi lepa along with Pathyadi kwath in management of Arsha |
|
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with age from 12 to 70 years, Patients who are suffering from Arsha 1st & 2nd degree, Irrespective of sex, Patients who were co-operative and ready give written consent.
|
|
| ExclusionCriteria |
| Details |
3rd & 4th degree piles, Thrombosed piles mass, Strangulated piles mass, Rectal polyp, Carcinoma of rectum, Portal hypertension, Patients suffering from HIV,HCV,HbSAg
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in clinical sign and symptom of Arsha |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Pathyadi Kwath (Bhaisjyaratnawali chapter-9)- content - Haritaki, Maricha, Vayavidanga, Chitrakamula, Yavani, Shunthi- take all in equal amount and make decoction used in management of Arsha. Haridradi lepa- content- Haridra, Kritvedhanchurna, katu tail apply locally on Haemorrhoid. |