| CTRI Number |
CTRI/2020/12/029758 [Registered on: 11/12/2020] Trial Registered Prospectively |
| Last Modified On: |
18/03/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Best Ayurvedic Treatment for Guda Bhramsha (Rectal Prolapse, Guda Horage Biluvudu in kannada, Kaacha Nikalana in Hindi) |
|
Scientific Title of Study
|
A randomized comparative clinical study on the efficacy of the Palasha Pratisaaraniya Ksharakarma and Thiersch operation in the management of Guda Bhramsha w.s.r. to Partial Rectal Prolapse. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakeshkumar S Gujar |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi University of Health Sciences, Bengaluru |
| Address |
Dr. Rakeshkumar S. Gujar. MS(Ay.), (PhD)(Ay.), Dept. of Shalyatantra (Surgery), OPD No. 3, BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vidyanagar, Bagalakote Road, Vijayapura.
Bijapur
KARNATAKA
586101
India |
| Phone |
9538140510 |
| Fax |
|
| Email |
rakeshkumarsgujar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rakeshkumar S Gujar |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi University of Health Sciencea, Bengaluru. |
| Address |
Dr. Rakeshkumar S. Gujar. MS(Ay.), (PhD)(Ay.), Dept. of Shalyatantra (Surgery), OPD No. 3, BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vidyanagar, Bagalakote Road, Vijayapura.
Bijapur
KARNATAKA
586101
India |
| Phone |
9538140510 |
| Fax |
|
| Email |
rakeshkumarsgujar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakeshkumar S Gujar |
| Designation |
Assistant Professor |
| Affiliation |
Rajiv Gandhi University of Health Sciences, Bengaluru. |
| Address |
Dr. Rakeshkumar S. Gujar. MS(Ay.), (PhD)(Ay.), Dept. of Shalyatantra (Surgery), OPD No. 3, BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vidyanagar, Bagalakote Road, Vijayapura.
Bijapur
KARNATAKA
586101
India |
| Phone |
9538140510 |
| Fax |
|
| Email |
rakeshkumarsgujar@gmail.com |
|
|
Source of Monetary or Material Support
|
| BLDEU’s Shri B. M. Patil Medical College Hospital and Research Centre, Vijayapura, 586101, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
BLDEAs AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
| Address |
Vidyanagar, Balagalakote Road, Vijayapura-586101, Karnataka, India. |
| Type of Sponsor |
Other [Private Ayurveda Medical College] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rakeshkumar S Gujar |
BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre |
BLDEAS AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Vijyanagar, Bagalakote Road.
Bijapur
KARNATAKA |
9538140510
08352240528
rakeshkumarsgujar@gmail.com |
| Dr Vikram U Sindagikar |
BLDEUs Shri B M Patil Medical College Hospital and Research Centre. |
Bangaramma Sajjan Campus, BLDEA Road,
Bijapur
KARNATAKA |
9844775210
08352262770
vikram.sindagikar@bldedu.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| BLDEA’s AVS Ayurveda Mahavidyalaya Hospital and Research Centre, Institutional Ethical Committee, Vijayapura, Karnataka, India. |
Approved |
| Institutional Ethics Committee BLDEU, Vijayapura, Karnataka, India. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K623||Rectal prolapse, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ksharakarma Procedure |
Palasha Pratisaaraniya Kshara will be applied to the complete lumen of the anal canal at and around the Pectinate line of the Anus, leaving behind the mucous membrane for preventing the post operative stricture.
Post Operatively Tablet Triphala Guggulu 500mg
2 tablets twice a day after food with Ushnodaka
Post Operatively Tablet Gandhaka Rasayana 500mg
2 tablets twice a day after food with Ushnodaka
|
| Comparator Agent |
Thiersch Operation |
Thiersch Operation will be done according to the Standard operative procedures mentioned in the Standard reference Text books of Surgery.
Post Operatively Tablet Triphala Guggulu 500mg
2 tablets twice a day after food with Ushnodaka
Post Operatively Tablet Gandhaka Rasayana 500mg
2 tablets twice a day after food with Ushnodaka
|
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Partial Rectal Prolapse namely, mass per anum, pain, occational bleeding per anum, pruritis ani, intermittent constipation, Intermittent incontinence mucoid discharge and occational constipation. |
|
| ExclusionCriteria |
| Details |
• Patients below the age of 16 yrs and above 60 yrs.
• Associated with any other ano-rectal diseases.
• Patient suffering from any systemic diseases.
|
|
|
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 |
Subjective parameters:
1. Bleeding PA(Per anum)
1. Intermittent constipation
2. Intermittent incontinence
3. Mass PA
4. Pruritis ani
Objective parameters:
1. Mucoid discharge
2. Mass per anum
Overall assessment:
1. Good response
2. Fair response
3. Poor response
|
Duration fixed for observing possible recurrence:
Duration of 60 days.
The changes will be observed before the treatment, on 4th day, 8th day and on 15th day after the treatment.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of the Patients with Partial Rectal Prolapse in the OPD and IPD section at BLDEAs AVS Ayurveda Mahavidyalaya Hopsital and Reseacrh centre and BLDEUs Shri B M Patil Medical College Hopsital and Reseacrh centre will be Discussed with the points related with the Age, Sex, Occupation, Diet, etc will be considered. |
One Year |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
04/01/2021 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not at published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The reference of Guda Bhramsha is well explained by the Sushruta, Father of Plastic Surgery in his Sushruta Samhita, 1500 B.C. Rectal Prolapse is a condition where the rectum protrudes beyond the anus. The protrusion of the mucosa or submucosa of the rectum is the partial prolapsed. The protrusion of the mass from the anal canal can be of the hemorrhoids or prolapsed of rectum as partial and the complete or polyps, etc. Both partial and complete varieties of rectal prolapse are extremely debilitating to the patients as it causes the discomfort of the prolapsing mass and variety of symptoms like rectal bleed, intermittent constipation or fecal incontinence. The management of the partial rectal prolapse can be conservative in cases of the temporary prolapses because of the Anal Mucosal stretch or permanent. Although, diverse modalities of surgical management of rectal prolapse are present, no single optimal procedure is proved and the choice of operation is determined by the patient’s age, sex, degree of incontinence, operative risk, as well as by the surgeon’s experience. In Ayurveda, Guda Bhramsa (Rectal prolapse) is explained by Acharya Susruta under Kshudra Rogas (chapter of minor diseases) and has elaborated its conservative management very beautifully. In present study the Ksharakarma pratisarana will be done and compared with the Thiersch operation, the data obtained will be statistically analyzed and results will be drawn. |