CLINICAL TRIAL OF SOOKTYN IN THE MANAGEMENT OF HYPERACIDITY SYNDROME AND PEPTIC ULCERS
By
Dr. C. SURYA PRAKASH RAO, M.S., F.I.C.S., FAIMS
Professor and Head
Department of Surgery, Rangaraya Medical College and Hospital, Kakinada, (A.P.)
INTRODUCTION
The clinical trial of the drug Sooktyn was undertaken to find its usefulness in the management of hyperacidity syndrome a common complaint and its incidence, is increasing in urban areas due to mental stress factors and irregularity and improper diet like consuming excessive spices, etc.
The Drug trial was conducted at the OPD of our Hospital during the period February 1993 to December 93. One hundred cases were included in the study. However, all the cases could not be followed up fully. There were only 73 cases whose records were complete. Only those cases who had Upper G.l. Endoscopy before starting the trial and had repeat G.l. Endoscopy were studied. They were in the age group of 18 years to 70 years. There were 12 Females and 61 Males. Out of these patients, 24 patients had received conventional treatment ranging from four to six weeks without relief. A few habitual to smoking and alcohol were asked to abstain from them totally. The patients were treated with Sooktyn for nine months, after which the results were assessed. Though Sooktyn treatment could have been discontinued after six months in the majority of cases who got excellent relief, the drug was continued for three more months to observe for any relapses and recurrence.
Seventy three cases of hyperacidity, syndrome whose case records were complete are assessed. They were subjected to thorough physical examination and the history of their complaints recorded in detail. All the patientsi had upper G.l. Endoscopy and this was repeated before assessing their improvement.
DRUG INFORMATION
Each tablet of Sooktyn contains:
| Sooktyn Bhasma | 112.5 mg |
| Kapur Kachli | 80.0 mg |
| Jatamansi | 30.0 mg |
| Ganthoda | 30.0 mg |
| Khurasani Ajavayan | 30.0 mg |
| Vacha | 30.0 mg |
| Datura leaves (Detoxicated) | 5.0 mg |
| Pipli moot | 30.0 mg |
Indications of Sooktyn are given as follows:
Hyperacidity, flatulence, dyspepsia, nausea, vomiting, acid eructation,
heart-burn, epigastric pain, duodenal and gastric ulcers.
Sooktyn has liver corrective, antacid, sedative, digestive and healing properties.
Dosage: 2-4 tabs, three to four times a day.
PATIENTS AND METHODS
One hundred cases were included in the clinical trial. However, as all the cases could not be followed up regularly only those cases whose upper G.l. Endoscopy could be done before starting treatment and was repeated after treatment could be assessed for results. There were 27 incomplete records, in 73 patients, the records were complete. Diagnosis was based on thorough medical examination and recording of the symptoms and endoscopic examination. There were 41 cases of duodenal ulcer, gastric ulcer 4, anastomotic ulcer 2, gastritis 18, duodenitis 8. Total 73 (Table 1)
| Table 1 Diagnosis | ||
| Diagnosis | No. of Cases | % |
| Duodenal Ulcer | 41 | 56.2 |
| Gastric Ulcer | 4 | 5.5 |
| Anastomotic Ulcer | 2 | 2.7 |
| Gastritis | 18 | 24.6 |
| Duodenitis | 8 | 11.0 |
| Total | 73 | 100 |
Patients were given 2 tablets of Sooktyn, three times a day half an hour after food. Patients were followed up every 15 days and their subjective improvement was noted with reference to reduction in intensity and duration of pain and severity of heart burn. During the period of medication those addicted to smoking and alcohol were advised to abstain from them. Clinical improvement was assessed by physical examination with special reference to improvement in general health and reduction of epigastric and hypogastric tenderness. A repeat endoscopic evaluation was done. Patients were treated for 9 months. Though in majority of cases who improved very well after 6 months medication could have been discontinued, they were continued for three more months to observe for any relapse and recurrences.
DISCUSSION
All the patients were treated for nine months, though majority of patients got relief in 6 months. This was done with the specific intention to see if there were any relapses and tecunences. Fhe patients were subjected to repeat upper-Gi Endoscopy. The relief of symptoms were assessed by physical examination and subjective relief of symptoms. Out of 41 cases of duodenal ulcer, healing of ulcer was seen in 36 cases and no change in 5 cases. Out of four cases of gastric ulcer, reduction in size of the ulcer was seen in two cases and there was no change in two cases. There was no change in 2 anastomotic ulcers. Among 18 cases of gastritis, marked endoscopic improvement is seen in all cases. Among 8 cases of duodenitis, there was endoscopic improvement in all cases. (Table 2)
| RESULTS TABLE 2 | |||||
| Diagnosis | Total No of Cases | Complete Relief / Endoscopic improvement | No Relief/ Partial Relief | ||
| No | No | % | No | % | |
| Duodenal Ulcer | 41 | 36 | 87.8% | 5 | 12.2% |
| Gastric ulcer | 4 | 2 | 50.0% | 2 | 50.0% |
| Anastomotic Ulcer | 2 | 0 | – | 2 | 100.0% |
| Gastritis | 48 | 18 | 100.0% | 0 | – |
| Duodenitis | 8 | 8 | 100.0% | 0 | – |
| Total | 73 | 64 | 87.7% | 9 | 12.3% |
| Endoscopic Observations (at the end of 2 months of treatment): | |||||
| No of Cases | Healing | No Change | |||
| Duodenal Ulcer | 41 | 36 | 5 | ||
| Gastric Ulcer | 4 | 2 | 2 | ||
| Anastomotic ulcer | 2 | – | 2 | ||
| Gastritis | 18 | 18 | – | ||
Sardesai1 in a study of fifty cases, had shown that Sooktyn gave excellent results in relief of heart-burn, acid-eructation, dyspepsia, pain after food, hyperacidity and peptic ulcers. Rangabashyam2 in a study of 50 cases showed that Sooktyn was found to be very effective in heartburn, acid regulation, dyspepsia and epigastric discomfort. It is helpful in healing of duodenal ulcer and in functional dyspepsia. It is not useful in anastomotic ulcer. Trivedi[1] in a study of 48 cases of hyperacidity showed that results were excellent in 41.6%, good in 29.2%, fair in 29.2%.
Shanker4 in a controlled study of 200 cases, showed clinical efficacy of Sooktyn and indigenous drug evaluated and compared with presently used histamine H2 receptor blocking agent Rantidine reveals – therapeutic superiority of Sooktyn over histamine H2 receptor blocking agent, ie 92% patients on Sooktyn achieved 100% cure of the disease while only 86% patients on Rantidine. No patient on Sooktyn needed any adjuvant therapeutic aid though 69% patients on Rantidine needed mild laxative to alleviate constipation & its sequelae. No patient on Sooktyn showed any recurrence or withdrawal effect and they too responded well to Sooktyn therapy. The present trial has given the success rate of Sooktyn treatment as 87 7%. There were no side effects and no recurrences especially when they were followed for three more months after 6 months treatment only to observe for recurrences and side effects.
CONCLUSIONS
- Sooktyn is an indigenous drug containing a combination of ingredients.
- Treatment with Sooktyn is cheaper in peptic ulcer diseases in comparison with treatment with H2 receptor antagonists.
- It has better patient compliance.
- With Sooktyn treatment there was complete relief in 87.7% of cases of hyperacidity syndrome and peptic ulcer.
- It is found to be useful in healing of duodenal ulcer.
- It reduces the severe discomforting symptoms in gastric ulcer and anastomotic ulcer.
- It is highly useful in reducing signs and symptoms of reflux gastritis.
- It has no side effects and there were no relapses and recurrences.
The conventional drugs in the treatment of hyperacidity and its sequelae acts to neutralize hyperacidity or suppress hypersecretion of gastric juice and act as symptom suppressive drugs. In the case of Sooktyn as this trial has shown, it has direct therapeutic effect in healing peptic ulcer diseases and relief of hyperacidity syndrome.
ACKNOWLEDGEMENT
I am thankful to the Superintendent of Rangaraya Medical College and Hospital for permission given to conduct this Clinical Trial and to send these findings for publication.
REFERENCES
Sardesai H.V., Desai M.B., Sooktyn, an Ayurvedic Drug in Hyper acidity Syndrome.
- Maharashtra Med. Journal 1965- 12 3 pp 267-69.
- Rangabashyam N., Durairaj K.,Sooktyn-A Trial with an Indigenous Drug for
Duodena’ Ulcer: Antiseptic: 1977; 74; 1 pp 27-29. - Trivedi S.W. (1985) Clinical Trial of Sooktyn, an Ayurvedic formulation in the
treatment of Hyperacidity. Indian Practitioner, 1995 XXX-7 pp 641
4. Shankar A. (1990) Sooktyn in the Management of Acid Peptic Disorders.
Antispetic: 1990:87; 6, pp 288-90