| CTRI Number |
CTRI/2025/04/084001 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative clinical study of standard ksharsutra and guggulu based Arshoghna Mahakashaya ksharsutra in the management of Arsha |
|
Scientific Title of Study
|
An open labelled active controlled randomized comparative clinical study to evaluate the efficacy of standard ksharsutra & guggulu based Arshoghna mahakashaya ksharsutra in the management of Arsha w.s.r.to haemorrhoids |
| 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 Ankit kumar gautam |
| Designation |
MS PG scholar |
| Affiliation |
OPD -3,Kunwar Shekhar Vijendra Ayurved Medical College and Research center,Gangoh, |
| Address |
OPD -3 , Kunwar shekhar vijendra ayurvedic medical College gangoh saharanpur u.p
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
8923422507 |
| Fax |
|
| Email |
ankitgautam174@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Narendra singh shekhawat |
| Designation |
MS Ayurveda Associate Professor department of Shalya Tantra |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research center,Gangoh |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University Gangoh,Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
9928297691 |
| Fax |
|
| Email |
dr.naren90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ayasha goyal |
| Designation |
assistant professor |
| Affiliation |
Kunwar Shekhar Vijendra Ayurved Medical College and Research Center |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University Gangoh,Saharanpur
Saharanpur
UTTAR PRADESH
247341
India |
| Phone |
7895676181 |
| Fax |
|
| Email |
goyalayasha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kunwar Shekhar Vijendra Ayurved Medical College and Reasearch centre shobhit University,Gangoh,Uttar Pradesh,247341 |
|
|
Primary Sponsor
|
| Name |
Dr Ankit Kumar Gautam |
| Address |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University Gangoh,Saharanpur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Narendra singh shekhawat |
Kunwar Shekhar Vijendra Ayurved hospital and Research center |
OPD no 3 Department of Shalya Tantra Kunwar Shekhar Vijendra Ayurved Medical College and Research center Shobhit University,Gangoh,Uttar Pradesh,247341 Saharanpur UTTAR PRADESH
Saharanpur
UTTAR PRADESH |
9928297691
dr.naren90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:O||Medical and Surgical. Ayurveda Condition: ARSAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: charak sutra 4/12, Procedure details: Standard ksharsutra ligation)
| | 2 | Intervention Arm | Procedure | - | kShArasUtra, क्षारसूत्र | (Procedure Reference: Ras tarangini 24/527-5, Procedure details: Guggulu based arshoghna mahakashaya ksharsutra ligation)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of arsha attending the o.p.d and i.p.d of our ayurved hospital & Research institute.
diagnosed cases of 3rd degree and 4th degree interno-external pile mass
Patient fit for operation |
|
| ExclusionCriteria |
| Details |
Pregnancy
Rectal carcinoma
Rectal prolapse
Uncontrolled HT &DM
Otherwise unfit for operation |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
We will assess bleeding per rectum and
pain per anum. |
We will assess bleeding per rectum and pain in ano at zerodays, 7thdays, and 14th day. follow up will be taken 21th and 28th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| we will assess swelling per anum and condition of anal sphincter tone. |
we will assess swelling per anum and condition of anal sphincter tone at zero, 7th, and 14th day. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 3 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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="0"
Months="10"
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
|
Arsha can be included as one of the lifestyle disorders caused due to sedentary lifestyle.the arsha is one among the ano-rectal disease which occurs in Gudapradesh(anus) as sadhyopranahara marma . Acharya Sushruta has mentioned several method of treatment .Among them Kshar sutra is mentioned in the treatment of arsha ,so I decided to evaluate the efficacy of standard Ksharsutra and gugglu based Arshoghna mahakashaya Ksharsutra in the management of arsha w s r to haemorrhoids . Therefore i have selected this trial,there will be 80 patients in two groups and in each group will be 40 patients aged between 18 to 65 years,the patients should be selected on the basis of inclusion and exclusion criteria . We will assess bleeding per rectum and pain per anum in subjective parameters and swelling per anum and condition of anal sphincter tone in objective parameter . We will assess bleeding per rectum, pain in ano, swelling per anum and condition of anal sphincter at zero, 7th, and 14th day. Follow up will be taken 21tn and 28th day. |