Efficacy of Shulaghna Saptak Vati in post operative pain management
- Conditions
- Third degree hemorrhoids. Ayurveda Condition: ARSAH,
- Registration Number
- CTRI/2025/04/084845
- Lead Sponsor
- Institute of Teaching and Research in Ayurveda, Jamnagar
- 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 willbe selected irrespective of the sex, religion, caste, occupation etc. from IPDof hospital I.T.R.A., Jamnagar. The selected patients will be divided intofollowing two groups by computer generated randomized method (Graph pad).
**GROUP-A (Trial group):**
• *Shulaghna Saptak Vati* (500mg) 2 tablets thrice dailywith lukewarm water after food for initial 7 post operative days after openHemorrhoidectomy
**In GROUP-B (Controlled group)**
· TabDiclofenac sodium 50mg one tablet twice daily with water, after food forinitial 7 post operative days after open Hemorrhoidectom**y.**
Observations will be recordedsystematically using a structured proforma .Statistical analysis will be donein order to evaluate and compare the effect of of *Shulghna Saptak Vati* and Tab Diclofenac in postoperative pain management after hemorrhoidectomy. Diclofenac analgesics arecommonly used to treat post operative pain. These conventional analgesics andanti-inflammatory drugs have been known of producing a wide range of adverseeffects. Hence there is an urgent need for research into novel analgesics thatare both safe and efficacious, with acceptable tolerability and demonstratedefficacy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 40
Post-open patient of Open haemorrhoidectomy with complaints of pain between the age group 18-60 years.
- Age less than 18 years and more than 60 years.
- 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.
- 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.
- Pregnant and lactating woman.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relief in the post operative pain of open haemorrhoidectomy patients 1st day and 7th day
- Secondary Outcome Measures
Name Time Method Absence of recurrence of pain in the folllow up period 22nd day
Trial Locations
- Locations (1)
Institute of Teaching and Research in Ayurveda Jamnagar
🇮🇳Jamnagar, GUJARAT, India
Institute of Teaching and Research in Ayurveda Jamnagar🇮🇳Jamnagar, GUJARAT, IndiaAMRUTHA SURESHPrincipal investigator9745362889amruthasheeja3@gmail.com