| CTRI Number |
CTRI/2019/09/021169 [Registered on: 11/09/2019] Trial Registered Prospectively |
| Last Modified On: |
09/09/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Trial of Shoolharan Yoga in Abdominal Pain |
|
Scientific Title of Study
|
Randomized Clinical Trial to Compare Efficacy of Shoolharan Yoga With And Without Bhavana Of Shoolprashaman Mahakashaya In Non-Traumatic Acute Abdominal Pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sushma Rawat |
| Designation |
Associate Professor |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University |
| Address |
P.G. Department of Rasashastra & Bhaishajya Kalpana, Uttarakhand Ayurved University, Rishikul Campus, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
9897151516 |
| Fax |
|
| Email |
sushmarawat27@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashish Kumar Tripathi |
| Designation |
P.G. Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University |
| Address |
P.G. Department of Rasashastra & Bhaishajya Kalpana, Uttarakhand Ayurved University, Rishikul Campus, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8840148496 |
| Fax |
|
| Email |
newcharak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashish Kumar Tripathi |
| Designation |
P.G. Scholar |
| Affiliation |
Rishikul Campus, Uttarakhand Ayurved University |
| Address |
P.G. Department of Rasashastra & Bhaishajya Kalpana, Uttarakhand Ayurved University, Rishikul Campus, Haridwar
Hardwar
UTTARANCHAL
249401
India |
| Phone |
8840148496 |
| Fax |
|
| Email |
newcharak@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ashish Kumar Tripathi |
| Address |
P.G. Department of Rasashtra & Bhaishajya Kalpana, Uttarakhand Ayurved University, Rishikul Campus, Haridwar |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Ashish Kumar Tripathi |
Rishikul Govt. Ayurvedic College OPD of Kaychikitsa/Shalyatantra/ Strirog/ Prasutitantra/Rasashastra |
Uttarakhand Ayurved University, Rishikul Campus, Haridwar
Hardwar
UTTARANCHAL |
08840148496
newcharak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mefenamic acid |
It is well known and widly used antispasmodic agent.
Dose- 500mg
Frequency- single dose
Rout of Administration- Oral (with water)
Duration- Only once |
| Intervention |
Shoolharan Yoga (SHY) |
It is herbomineral formulation, mentioned in AFI with the indications like Shool (Colicky Pain), Grahani (Malabsorption Syndrome), Atisaar (Diarrhoea), Gulma (Abdominal lump), Agnimandya (Digestive Impairment), Ajirna (Dyspepsia) and general prescribed dose is 500 mg.
Dose- 500mg
Frequency- single dose
Rout of Administration- Oral (with water)
Duration- Only once |
| Intervention |
Shoolharan Yoga with Bhavana of Shoolprashaman Mahakashay (SHYB) |
Modefied vrsion of Shoolharan Yoga, formulation mentioned found more potent antispasmodic than SHY in In-vivo studyand In-vitro study, performed as a part of thesis work(By the same investigator).
Dose- 500mg
Frequency- single dose
Rout of Administration- Oral (with water)
Duration- Only once |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Chronicity not more than 10 days
Abdominal pain (Colicky type)
|
|
| ExclusionCriteria |
| Details |
. Age less than 20 & more than 60 years.
. Traumatic condition
. Cases which require urgent surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Scoring will be done on the basis of severity of pain-
No Pain 0
Mild Pain 1
Moderate Pain 2
Severe Pain 3
|
Same day after 30 minutes, 1hour, 2hour & 3 hour of drug intake |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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
|
within 24 hours of administration |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/10/2019 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |