CTRI Number |
CTRI/2025/04/084845 [Registered on: 15/04/2025] Trial Registered Prospectively |
Last Modified On: |
15/04/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Efficacy of Shulaghna Saptak Vati in post operative pain management |
Scientific Title of Study
|
Clinical Efficacy of Shulaghna Saptak Vati in post operative pain management after open Haemorrhoidectomy- A Randomized Controlled Clinical Trial |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
AMRUTHA SURESH |
Designation |
PG SCHOLAR |
Affiliation |
Institute of Teaching and Research in Ayurveda |
Address |
Department of Shalya Tantra
Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
9745362889 |
Fax |
|
Email |
amruthasheeja3@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Prof Dr T S DUDHAMAL |
Designation |
H.O.D |
Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
Address |
Department of Shalya Tantra
Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
9745362889 |
Fax |
|
Email |
drtsdudhamal@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Prof Dr T S DUDHAMAL |
Designation |
H.O.D |
Affiliation |
Institute of Teaching and Research in Ayurveda, Jamnagar |
Address |
Department of Shalya Tantra
Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar GUJARAT 361008 India |
Phone |
9745362889 |
Fax |
|
Email |
drtsdudhamal@gmail.com |
|
Source of Monetary or Material Support
|
Institute of Teaching and Research in Ayurveda Jamnagar |
|
Primary Sponsor
|
Name |
Institute of Teaching and Research in Ayurveda, Jamnagar |
Address |
Institute of Teaching and Research in Ayurveda , Jamnagar 361008 |
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 |
AMRUTHA SURESH |
Institute of Teaching and Research in Ayurveda Jamnagar |
Shalya Tantra IPD
Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar GUJARAT |
9745362889
amruthasheeja3@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional ethics committee Institute of Teaching and Research in Ayurveda Jamnagar |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:K642||Third degree hemorrhoids. Ayurveda Condition: ARSAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Shulaghna Saptak Vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: Yes(details: WATER), Additional Information: | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Diclofenac Sodium | Dosage 50 mg Two times in a day for 7 days |
|
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Post-open patient of Open haemorrhoidectomy with complaints of pain between the age group 18-60 years |
|
ExclusionCriteria |
Details |
1. Age less than 18 years and more than 60 years.
2. Patients who underwent operation for hemorrhoid associated with fissure or fistula-in-ano, who is having complications like bleeding from the operated site and surgical site infection IBS OR diagnosed cases Crohn’s disease, in immunocompromised states like HIV, HbsAg, VDRL, HCV
3. Known cases of Malignancy, Tuberculosis.
4. Uncontrolled Hypertension (diastolic BP greater than 90mmHg, Systolic BP greater than 160mmHg), uncontrolled Diabetes Mellitus (FBS greater than 110mg/dl, PPBS greater than 140mg/dl), Cardiac disorders.
5. Pregnant and lactating woman.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Relief in the post operative pain of open haemorrhoidectomy patients |
1st day and 7th day |
|
Secondary Outcome
|
Outcome |
TimePoints |
Absence of recurrence of pain in the folllow up period |
22nd day |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 |
Date of First Enrollment (India)
|
16/06/2025 |
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
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Arsha is one among the eight grave diseases mentioned in Susruta Samhita. It can be compared with hemorrhoids in Western system of medicine. At least 50% of people over the age of 50 years have some degree of symptom of hemorrhoid. Open Haemorrhoidectomy (Milligan Morgan) is one among the treatments of choice in 3rd and 4th degree hemorrhoids. However it is associated with significant amount of post operative pain, which may increase the patient sufferings and can lead to post operative adverse events such as urine retention. Diclofenac analgesics are commonly used to treat post operative pain. These conventional analgesics and anti-inflammatory drugs have been known of producing a wide range of adverse effects. Hence there is an urgent need for research into novel analgesics that are both safe and efficacious, with acceptable tolerability and demonstrated efficacy. Shulaghna Saptaka Vati is a polyherbal formulation which is having proven analgesic and anti-inflammatory in animal models. This formulation contains various chemical constituents such as B-boswellic acid, Glycerrhizine, Flavonoids, Tinosporin, Saponins etc. which can act in both peripheral and central analgesic mechanism. Data regarding the oral acute toxicity studies are also carried out in animals. Till date no human clinical research works on pain management potential of Shulaghna Saptaka Vati are available. Thus, this drug has been selected in comparison with the most commonly used diclofenac analgesics in post operative pain management of open hemorrhoidectomy.40 post operative cases of open hemorrhoidectomy will
be selected irrespective of the sex, religion, caste, occupation etc. from IPD
of hospital I.T.R.A., Jamnagar. The selected patients will be divided into
following two groups by computer generated randomized method (Graph pad).
GROUP-A (Trial group):
•
Shulaghna Saptak Vati (500mg) 2 tablets thrice daily
with lukewarm water after food for initial 7 post operative days after open
Hemorrhoidectomy
In GROUP-B (Controlled group)
·
Tab
Diclofenac sodium 50mg one tablet twice daily with water, after food for
initial 7 post operative days after open Hemorrhoidectomy.
Observations will be recorded
systematically using a structured proforma .Statistical analysis will be done
in order to evaluate and compare the effect of of Shulghna Saptak Vati and Tab Diclofenac in post
operative pain management after hemorrhoidectomy. Diclofenac analgesics are
commonly used to treat post operative pain. These conventional analgesics and
anti-inflammatory drugs have been known of producing a wide range of adverse
effects. Hence there is an urgent need for research into novel analgesics that
are both safe and efficacious, with acceptable tolerability and demonstrated
efficacy.
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