Clinical Trial of Shoolharan Yoga in Abdominal Pain
- Conditions
- Other specified diseases of the digestive system,
- Registration Number
- CTRI/2019/09/021169
- Lead Sponsor
- Ashish Kumar Tripathi
- Brief Summary
**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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
Chronicity not more than 10 days Abdominal pain (Colicky type).
- Age less than 20 & more than 60 years.
- Traumatic condition .
- Cases which require urgent surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Scoring will be done on the basis of severity of pain- Same day after 30 minutes, 1hour, 2hour & 3 hour of drug intake No Pain0 Same day after 30 minutes, 1hour, 2hour & 3 hour of drug intake Mild Pain 1 Same day after 30 minutes, 1hour, 2hour & 3 hour of drug intake Moderate Pain 2 Same day after 30 minutes, 1hour, 2hour & 3 hour of drug intake Severe Pain 3 Same day after 30 minutes, 1hour, 2hour & 3 hour of drug intake
- Secondary Outcome Measures
Name Time Method Frequency of the abdominal pain will be scored- Repetition of Pain EpisodesScore
Trial Locations
- Locations (1)
Rishikul Govt. Ayurvedic College OPD of Kaychikitsa/Shalyatantra/ Strirog/ Prasutitantra/Rasashastra
🇮🇳Hardwar, UTTARANCHAL, India
Rishikul Govt. Ayurvedic College OPD of Kaychikitsa/Shalyatantra/ Strirog/ Prasutitantra/Rasashastra🇮🇳Hardwar, UTTARANCHAL, IndiaAshish Kumar TripathiPrincipal investigator08840148496newcharak@gmail.com