CTRI Number |
CTRI/2022/10/046374 [Registered on: 11/10/2022] Trial Registered Prospectively |
Last Modified On: |
10/10/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Surgical/Anesthesia |
Study Design |
Single Arm Study |
Public Title of Study
|
Role of Mochras coated ksharsutra in the management of Arsha i.e internal haemorrhoids. |
Scientific Title of Study
|
A Clinical study to evaluate the efficacy of Mochras ksharsutra in the management of Arsha ( IInd & IIIrd degree internal haemorrhoids) |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Rajiv Soni |
Designation |
Assistant Professor and PhD Scholar |
Affiliation |
UPGIASR |
Address |
PG Department of Shalya Tantra university post graduate institute of ayurved studies and research DSRRAU Karwad Jodhpur
Jodhpur RAJASTHAN 342037 India |
Phone |
8209643872 |
Fax |
|
Email |
rajivsoni10@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Rajesh Kumar Gupta |
Designation |
Associate Professor and HOD |
Affiliation |
UPGIASR |
Address |
PG department of Shalya Tantra university post graduate institute of ayurved studies and research, Karwad
Jodhpur RAJASTHAN 342037 India |
Phone |
9636520573 |
Fax |
|
Email |
guptadrrajeshkumargupta@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Rajesh Kumar Gupta |
Designation |
Associate Professor and HOD |
Affiliation |
UPGIASR |
Address |
PG department of Shalya Tantra university post graduate institute of ayurved studies and research, Karwad
Jodhpur RAJASTHAN 342037 India |
Phone |
9636520573 |
Fax |
|
Email |
guptadrrajeshkumargupta@gmail.com |
|
Source of Monetary or Material Support
|
PG Department of Shalya Tantra University Post Graduate Institute of Ayurved Studies and Research DSRRAU Nagaur Road NH 62 Karwad Jodhpur Rajasthan
Depty director of government ayurved department, N.G.O. or any other institute. |
|
Primary Sponsor
|
Name |
University Post Graduate Institute of Ayurved Studies and Research DSRRAU |
Address |
PG Department of Shalya Tantra University Post Graduate Institute of Ayurved Studies and Research DSRRAU Nagaur Road NH 62 Karwad Jodhpur Rajasthan 342037 |
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 Rajiv Soni |
University Post Graduate Institute of Ayurved Studies and Research Jodhpur |
PG Department of Shalya Tantra (OPD NO 14) University Post Graduate Institute of Ayurved Studies and Research Jodhpur Jodhpur RAJASTHAN |
8209643872
rajivsoni10@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee University Post Graduate Institute of Ayurved Studies and Research |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K625||Hemorrhage of anus and rectum. Ayurveda Condition: ARSAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | kShArasUtra, कà¥à¤·à¤¾à¤°à¤¸à¥‚तà¥à¤° | (Procedure Reference: chakkra dutta arshobhagandaram 5/148, Procedure details: Mochras coted kshar sutra Para Surgical Procedure)
|
|
|
Inclusion Criteria
|
Age From |
20.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
1 Patient will be selected randomly, irrespective of sex, economical status and education.
2 Patients attended with the classical signs and symptoms of Arsha ( IInd & IIIrd degree internal Haemorrhoids).
3 Patients who will be ready to give written informed consent. |
|
ExclusionCriteria |
Details |
1 Patients with other systemic illness like uncontrolled Diabetes mellitus, malignancy etc.
2 HBsAg and Retrovirus positive patients.
3 Secondary internal haemorrhoids because of other systemic disorders.
4 Internal hemorrhoids with other associated Ano-rectal diseases / Colon diseases.
5 Infective and Neoplastic conditions of rectum/Anus.
6 Rectal prolapse, Pelvic pathology and Pregnancy. |
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Other |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
1 Raktasrava (Bleeding per rectum)
2 Prolapse of the pile mass.
3 Pain (Anal Discomfort)
4 Mucoid Discharge.
5 Rate of sloughing of pile mass.
|
1 Raktasrava (Bleeding per rectum)
2 Prolapse of the pile mass.
3 Pain (Anal Discomfort)
4 Mucoid Discharge.
5 Rate of sloughing of pile mass.
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1 Recovery time.
2 Time to return to work.
3 Length of Hospital Stay.
4 Parental/patient satisfaction.
|
8 weeks |
|
Target Sample Size
|
Total Sample Size="100" Sample Size from India="100"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
01/11/2022 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
(Ano-rectal region).Symptoms of Aabhyantara Arsha closely resemble to the clinical features of Internal Haemorrhoids. Arsha is being described by all the classical texts of Ayurveda. Acharya Sushrutaand Vagbhataeven placed this disorder in the “ASHTA MAHAGADAâ€, (Eight grave diseases). It gives trouble to the person like as an enemy which was explained by Acharyas. National Center for Health Statistics Johanson and Sonnenberg found that 10 million people in United States complained of Haemorrhoids, Prevalence rate of 4.4 %. In both sexes, a peak inprevalence was noted from age 45–65 yr, with a subsequent decrease after age 65 yr. The development of haemorrhoids before age 20 yr was unusual. A recent prospective study of screening colonoscopy patients revealed the presence of haemorrhoids in 38.9%, with 44.7% of those patients suffering from haemorrhoidal symptoms. Acharya Sushruta has Arsha (Haemorrhoids) is one of the commonest ailments occurring in Guda Pradesha described four principle therapeutic measures in treating the Arsha. They are Aushadhi (Medicinal), Ksharkarma (Chemical cauterization), Agnikarma (Thermal cauterization) and Shastrakarma (Surgical excision). Sushruta speaks much more about Kshara Karma while going through the chapter for treatment of “Arshaâ€, it becomes quite evident that Kshara Karma has been considered as the most successful, simple and non-invasive para-surgical measure. Here I am evaluating the efficacy and advantages of Mochras ksharsutra Ligation in the Management of Arsha (2nd& 3rd degree internal Haemorrhoids). • Ayurveda is well known for the treatment of Arsha with Ksharsutra Ligation, due to yielding negligible rate of recurrence, cost effective, lesser pain, no bleeding, no infection, no anal incontinence and requiring minimal hospitalization during treatment with better recovery. Mochras i.e gum of salmalia Malabarica is easily available drug, can keep for longer period ,very safe to use and used to reduces the side effect of kshar karm i.e pain, Bleeding, Prolapse of the pile mass, burning sensation,,discharge ect. while snuhi sheer is difficult to available, can’t keep for longer period, unsafe and many side effects. Hence to check the quality of MOCHRAS explained by Charak, Sushruta, Bhavprakash ect. Mochras ksharsutra is made for treatment of Arsha (haemorrhoids). Thus present study has been planned. The aim of the present study is to develop more simplified and ideal therapy with addition of more healing effect and to reduce early & late post operative complication with less discomfort to the patient regarding Bleeding, pain, Prolapse of the pile mass, burning sensation, discharge ect. and Premature sloughing of pile mass. Mochras is safe and easily available drug .Hence Mochras ksharasutra will be prepared for ligation |