| CTRI Number |
CTRI/2025/01/079157 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of Saindhavadi yoga in the management of constipation in children |
|
Scientific Title of Study
|
An open label Randomized placebo controlled clinical trial on Saindhavadi Yoga in the management of Vibandha W.S.R. to Functional Constipation in Children. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vanshika Dhama |
| Designation |
M D Scholar |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Kaumarabhritya OPD G13 State Ayurvedic College
and Hospital Tulsidas Marg, Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
8923615305 |
| Fax |
|
| Email |
vanshikadhama20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Laxmi |
| Designation |
Asst. Professor |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Kaumarabhritya OPD G13 State Ayurvedic College
and Hospital Tulsidas Marg, Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxmi |
| Designation |
Asst. Professor |
| Affiliation |
state ayurvedic college and hospital Lucknow |
| Address |
Department of Kaumarabhritya OPD G13 State Ayurvedic College
and Hospital Tulsidas Marg, Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003
India
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9792446688 |
| Fax |
|
| Email |
lakshmiomsingh@gmail.com |
|
|
Source of Monetary or Material Support
|
| state ayurvedic college and hospital, Turiyaganj, Lucknow Pincode 226003 |
|
|
Primary Sponsor
|
| Name |
State ayurvedic college and hospital Lucknow |
| Address |
Department of Kaumarabhritya OPD G13 State Ayurvedic College
and Hospital Tulsidas Marg, Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH
226003 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Vanshika Dhama |
State Ayurvedic College and Hospital |
Pg Department of
Kaumarabhritya OPD-1 State
Ayurvedic College and
Hospital Tulsidas Marg, Lucknow
226003
Lucknow
UTTAR PRADESH |
8923615305
vanshikadhama20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Ayurvedic College and Hospital Lucknow |
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. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Saindhavadi yoga, Reference: Ravanakrita kumaratantra, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: ghrita), Additional Information: - | | 2 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Godhuma vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: ghrita), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children fulfilling ROME IV Criteria.
Most include 2 or more following occurring at least once a week. for a minimum 1 month with insufficient criteria to diagnose irritable bowel syndrome.
1. Two or fewer defecations in the toilets per week in a child of a
developmental age of at least 4 year
2. At least one of fecal incontinence per week.
3. History of retentive posturing or excessive volitional stool retention.
4. History of painful or hard bowel movement.
5. Presence of a large fecal mass in the rectum.
6. History of large diameter stool that can obstruct the toilets after appropriate evaluation, the symptoms cannot be fully explained by another medical condition. |
|
| ExclusionCriteria |
| Details |
1. Children with organic disorders as Hischsprung disease should be excluded.
2. Children Suffering from liver disorders should be excluded.
3. Children suffered with other systemic illness like T.B. HIV should be excluded.
4. 4. Drug induced constipation should be excluded (drugs such as opiates, anticholinergic agents, phenobarbitone, vincristine and lead).
5.Children not fulfilling the criteria of Rome IV. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To improve the quality of life in Children suffering from functional constipation. |
At 75th day of completing clinical trial. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of saidhavadi yoga. |
1st day, 15th day, 30th day, 45th day, 60th day, 75th day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
03/02/2025 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Functional constipation is one of the lifestyle disorders.To improve the quality of life suffering from functional constipation therefore I selected this clinical trial. Clinical trial will be done on Saindhavadi yoga . Maximum 60 Functional constipation diagnosed children aged 3-12 yr clinical studies into two group of treatment modules. Each segment of the treatment module will be of 2 months after each treatment there is a gap of 15 days .Total duration of trial is 75 days. Follow up will be performed before intervention and after 15 days of each treatment module . A follow up will be done after 15 days of complete clinical trial |