| CTRI Number |
CTRI/2020/05/025259 [Registered on: 20/05/2020] Trial Registered Prospectively |
| Last Modified On: |
06/05/2020 |
| 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
|
A clinical study to compare effect of madhughrita pratisaran with calcium dobesilate in management of raktarsha(bleeding piles) |
|
Scientific Title of Study
|
A randomized comparative clinical trial to evaluate the efficacy of madhughrita pratisaran with calcium dobesilate in raktarsha |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nutan Valmik Sanap |
| Designation |
PG scholar |
| Affiliation |
PDEAS College of ayurved and research centre |
| Address |
Ayurved rugnalay and sterling multispeciality hospital, Sector no 27,pradhikaran, Nigdi Pune.
Department Of Shalyatantra ,OPD No.123. PDEAS College of ayurved and research centre,Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8623052764 |
| Fax |
|
| Email |
nvsanap007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bharat Oza |
| Designation |
Associate Professor Shalya tantra department |
| Affiliation |
PDEAS College of ayurved and research centre |
| Address |
Ayurved rugnalay and sterling multispeciality hospital, Sector no 27,pradhikaran, Nigdi Pune
Department Of Shalyatantra ,OPD No.123. PDEAS College of ayurved and research centre,Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
9970254593 |
| Fax |
|
| Email |
drbharat_oza@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Nutan Valmik Sanap |
| Designation |
PG scholar |
| Affiliation |
PDEAS College of ayurved and research centre |
| Address |
Ayurved rugnalay and sterling multispeciality hospital, Sector no 27,pradhikaran, Nigdi Pune.
Department Of Shalyatantra ,OPD No.123. PDEAS College of ayurved and research centre,Sector No. 27, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8623052764 |
| Fax |
|
| Email |
nvsanap007@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEA college of ayurved research centre, sector no. 27, pradhikaran, nigdi, pune 411044 |
|
|
Primary Sponsor
|
| Name |
PDEA college of ayurved research centre |
| Address |
sector no. 27, pradhikaran, nigdi, pune 411044 |
| Type of Sponsor |
Private 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 |
| Nutan Valmik Sanap |
Ayurved Rugnalay and sterling multispeciality hospital, Nigdi |
Sector no 27, pradhikaran Nigdi, Pune 411044
Pune
MAHARASHTRA |
8623052764
nvsanap007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K648||Other hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Calcium dobesilate |
Group B will be treated with Calcium dobesilate daily for 7 days with follow up on 3rd, 5th, 7th day |
| Intervention |
Madhughrita pratisaran |
Group A will be treated with madhughrita pratisaran daily for 7 days with follow up on 3rd, 5th, 7th day |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Age between 20-50 yrs
2 Both male and female and others
3 patients with 1st 2nd, 3rd degree haemorrhoids
4 bleeding piles
|
|
| ExclusionCriteria |
| Details |
1 Prolapsed of the rectum
2 k/c/o Fistula in ano
3 perineal Abscess
4 k/c/o Malignancy
5 K/C/O Crohns disease
6 K/C/O Ulcerative colitis
7 Rectal polyp
8 K/C/O Diverticulitis
9 K/C/O Hypertension
10 Bleeding Disorders
11 Hb % less than 7 gm%
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare efficacy of Madhughrita Pratisaran and Calcium dobesilate applied locally thrice a day for 7 days in the management of Raktarsha. |
7 days with follow up on 3rd, 5th and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the adverse effect of Madhughrita Pratisaran if any |
7 days with follow up on 3rd, 5th and 7th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/05/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
One
of the most common ano-rectal conditions is Hemorrhoids. Cause may be in
relation to the food or the faulty life style. In common language it is
referred as Piles. The prevalence rate of piles is 4.4% in the world that is
about 10 million people.The diseases that is troubling the human being
since the time immemorial is the Arsha because of its manifestation at the Guda
Pradesh which is the “ Moola of Shariraâ€.Haemorrhoids, also called piles, are vascular
structures in the anal canal. They become a disease when swollen or inflamed.
The signs and symptoms of haemorrhoids depend on the type present. Internal
haemorrhoids are usually present with painless, bright red rectal bleeding when
defecating. External haemorrhoids often results in pain and swelling in area of
the anus.
Drugs taken for study:
1. Madhu
|
Guna
|
Madhur
Kashayanuras , Ruksha, Shita, Laghu, Pishcchil, Yogvahi mrudu
|
|
Karma
|
Lekhan,
Shodhan, Ropan, Agnidipan
|
|
Doshaghnatwa
|
Tridosha
prashaman
|
|
Vikar
nashakatva
|
Arsha,Kushtha,
Meha, Badhdamalata
|
|
Dhatugamitva
|
Meda,
Majja, Medhaprasadaka,
|
2. Ghrita
|
Guna
|
Madhur, Sheet, Madhurvipaki
|
|
Karma
|
Dahaprashaman,
swara varnya prasadanm,
Rajoroadh
|
|
Doshanghanta
|
Vataprashaman,
pitta prashamana shodhan
|
|
vikarnashtva
|
Visarp, unmad,
shotha, kashtha atarava,
|
3. Calcium dobesilate-
it is combination of calcium dobisilate 0.25%+ hydrocortisone 0.25%+
lignocaine 3%+ zinc oxide 5%
It is a used for local application it is
local anesthetic, anti inflammatory and venous decongestant and improves vinous
tone In my study I am going to study and compare effect of Madhughrita Pratisaran with Calcium dobesilate in management of Bleeding Piles.
|