Randomized Clinical Trial to Compare Efficacy of Shoolharan Yoga With And Without Bhavana Of Shoolprashaman Mahakashaya In Non-Traumatic Acute Abdominal Pain

PLAN OF STUDY

1. Selection of patients: total 30 patients of abdominal pain will be selected from OPD/ IPD of Rishikul Campus, Haridwar. The study will be conducted on patients randomly divided into three groups that mean 10 patients in each group. Selection of patient will be done on detailed clinical history, physical examination & other required investigations irrespective of their gender, caste & greed.

2. Selection of drug:   sample 1 (Shoolharan Yoga), Sample-2 (Shoolharan Yoga with bhavana of Shoolprashaman Mahakashaya) will be used in group-1 & group-2 respectively and Mefanamic acid will be used as standard drug in group-3.

3**.  Dose of Drug**: 500 mg (for sample-1 & sample-2 each)

4. Duration of study: 60 days

5. Types of study: Single blind.

6**. Assessment & follow-up**: it will be done on same day after 30 min, 1 hour, 2 hour & 3 hours of drug intake & follow up will be done if required.

7. Inclusion criteria:

a). age group between 20-60 years.

b) Chronicity not more than 10 days.

c). Abdominal pain (Colicky type)

8.Exclusion criteria:

a). Age less than 20 & more than 60 years.

b). Traumatic condition

c). Cases which require urgent surgery

 9. Criteria of withdrawal:

a) Personal matters

b) Intercurrent illness

c) Aggregations of complaints

d) Any other difficulties

           10. Criteria of assessment (Scoring criteria):

Scoring will be done on the basis of severity of pain-

Severity of Pain

Score

|No Pain

0

|Mild

1

|Moderate

2

|Severe

3

  Efficacy will be scored on the basis of time duration in reduction of severity of pain-

Time Duration

Score

|Less than 1 hour

4

|1-3 hours

3

|3-5 hours

2

|5-7 hours

1

|No reduction in severity

0

 Frequency of the abdominal pain will be scored-

Repetition of Pain Episodes

Score

|No Further Episode

0

|1-2 times/day

1

|3-4 times/day

2

|5-6 times/day

3

|More than 6 times/day

4

 11. Observations: Change in severity of associated symptoms will be observed along with abdominal pain.

12. Investigation: If necessary, to exclude surgical & gynaecological cases.

12. Conclusion: It will be done on basis of observation which is done on subjective parameters. The result will be analyzed statistically& discussed.