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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 Disorders” 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.

 
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