| CTRI Number |
CTRI/2018/09/015826 [Registered on: 25/09/2018] Trial Registered Prospectively |
| Last Modified On: |
12/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Ayurveda Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post operative pain management of anorectal surgeries using herbal rectal suppository |
|
Scientific Title of Study
|
A Clinical study to evaluate the effect of gandhaka rasayana rectal suppository in
post operative pain management of ano rectal disorders |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ranjani Deshpande |
| Designation |
PG Scholar (M.S.,) |
| Affiliation |
Govt Ayurveda Medical College,Bengaluru, SJIIM |
| Address |
Government Ayurveda Medical College
Dhanvantari Road
Bengaluru Sri Jayachamarajendra Institute of Indian Medicine
Dhanvantari Road
Bengaluru Bangalore KARNATAKA 560009 India |
| Phone |
09481776791 |
| Fax |
|
| Email |
ranjani.rsdeshpande@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa PNguide |
| Designation |
Associate Professor, Dpt of shalya tantra, Govt Ayurvedic Medical College, Bengaluru-09 |
| Affiliation |
Govt Ayurvedic Medical College,Bengaluru, SJIIM |
| Address |
Government Ayurvedic Medical College
Dhanvantari Road
Bengaluru Sri Jayachamarajendra Institute of Indian Medicine
Dhanvantari Road
Bengaluru Bangalore KARNATAKA 560009 India |
| Phone |
9886792113 |
| Fax |
|
| Email |
drshilpamys@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ranjani Deshpande |
| Designation |
PG Scholar (M.S.,) |
| Affiliation |
Govt Ayurveda Medical College,Bengaluru, SJIIM |
| Address |
Government Ayurveda Medical College
Dhanvantari Road
Bengaluru Sri Jayachamarajendra Institute of Indian Medicine
Dhanvantari Road
Bengaluru Bangalore KARNATAKA 560009 India |
| Phone |
09481776791 |
| Fax |
|
| Email |
ranjani.rsdeshpande@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurveda Medical College, Bengaluru |
|
|
Primary Sponsor
|
| Name |
Government Ayurveda Medical CollegeBengaluru |
| Address |
Government Ayurveda Medical College
Dhanvantari Road
Bengaluru |
| 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 Shilpa PN |
Government Ayurveda Medical College Bengaluru |
Department of PG studies in Shalya Tantra Bangalore KARNATAKA |
9886792113
drshilpamys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Ayurveda Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K605||Anorectal fistula, (2) ICD-10 Condition: K601||Chronic anal fissure, (3) ICD-10 Condition: K92||Other diseases of digestive system, (4) ICD-10 Condition: K648||Other hemorrhoids, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac rectal suppository |
one diclofenac suppository of 50mg each will be inserted every 12th hourly post operatively for 5days |
| Intervention |
Gandhaka Rasayana Rectal Suppository |
each rectal suppository will contain 0.3grams of gandhaka rasayana and 2 suppositories
will be inserted at a time every 12th hourly post operatively for 5days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) patients between age group of 20-60yrs
2)Patients undergoing fissurectomy, haemorrhoidectomy and fistulotomy
|
|
| ExclusionCriteria |
| Details |
1) pregnant women
2)Fissure/haemorrhoid/fistula in ano with Inflammatory Bowel Disease and Crohn’s disease.
3)Patients with immunocompromised state.
4)Patients suffering from systemic diseases like DM,Tuberculosis,rheumatoid arthritis etc.
5)Positive cases for Human Immunodeficiency Virus (HIV), Venereal Disease Research Laboratory (VDRL) and hepatitis-B
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to attain Post operative pain management |
5days , postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To also elicit any wound healing activity along with the same |
5days, post operatively |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/09/2018 |
| Date of Study Completion (India) |
27/02/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
TITLE: “A Clinical Study To Evaluate The Effect Of Gandhaka Rasayana Rectal Suppository In Post Operative Pain Management Of Ano-Rectal Disordersâ€
JOURNAL: Journal of Ayurveda and Integrated Medicine
STATUS: Under Publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Suppositories are one such dosage form that
can be used in post-operative pain especially in anorectal surgeries. Sodium
diclofenac is of NSAID category which has been shown to have analgesic effects
in various conditions.
Though diclofenac rectal suppository
is widely used they are associated with high risk factors and warnings like
headache, dizziness, light headedness, drowsiness, loss of appetite, local
rectal irritation, ringing in the ears, vision loss, rectal bleeding. Other
serious side effects like black stools, persistent stomach pain,
vomit that looks like coffee grounds could develop. Allergic reactions like
rashes, itching, swelling, trouble breathing could also develop as an adverse
effect of diclofenac suppository.5
According to Ayurveda, parikartika is a
vyadhi caused by vata and pitta dosha and anuvasana basti is treatment
explained. But this involves a lot of exercise.The patient should be advised
with pathya and apathya of both ahara and vihara, the basti dravya must be
warmed priorly before instillation, care should be taken to avoid basti
vyapaths and the patient will always need the assistance of his doctor for
treatment. Most of these problems can be avoided by using an appropriate
dravya(vata pitta hara, shoola hara) converted to a suppository form by being
molded with a snigdha dravya which still satisfies the definition of basti(vas
nivase) by staying in the rectum for a stipulated period of time and
facilitating slower drug release to provide a better action.
To prevent all these problems and to
prevent the adverse effects of allopathic drugs the present study is planned to
evolve an effective treatment by ayurvedic approach in post-operative pain
management. In this study an attempt is made to evaluate the efficacy of
Gandhaka Rasayana rectal suppository which is tridosha shamaka, vatamaya
nivaraka agnivardhaka, rasayana and most importantly shoola hara. |