| CTRI Number |
CTRI/2025/02/080522 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effect of Dhatryadi Syrup in the management of Malavibandha in preschool children. |
|
Scientific Title of Study
|
A randomized controlled clinical study to evaluate the efficacy of Dhatryadi Syrup in the management of Malavibandha in the preschool children (3 to 6 years). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aditi Avinash Khadamkar |
| Designation |
PG Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurveda and Research Centre Balrog department Third floor Pradhikaran Nigdi Pune 411044
Maharashtra
India
PDEAs College of Ayurveda and Research Centre Third floor Balrog department Pradhikaran Nigdi Pune 411044
Maharashtra
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9423813346 |
| Fax |
|
| Email |
aditikhadamkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurveda and Research Centre Third floor Balrog department Nigdi Pune 411044
Pune
Maharashtra
India
PDEAs College of Ayurveda and Research Centre Third floor Balrog department Nigdi Pune 411044
Maharashtra
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sudha Singh |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurveda and Research Centre Third floor Balrog department Nigdi Pune 411044
Maharashtra
India
PDEAs College of Ayurved and Research Centre Third floor Balrog department Nigdi Pune 411044
Maharashtra
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9975404439 |
| Fax |
|
| Email |
drsudha2010@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune 411044 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
PDEAS College of Ayurved and Research Centre |
| Address |
PDEAS College of Ayurved and Research Centre Balrog Department Third floor Nigdi Pune 411044
Maharashtra
India |
| Type of Sponsor |
Private 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 Aditi Avinash Khadamkar |
Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi |
OPD No 118 Ground floor Sector 27 Nigdi Pradhikaran Pune 411044
Maharashtra
Pune
MAHARASHTRA |
9423813346
aditikhadamkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Chairperson Ethic Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K00-K95||Diseases of the digestive system. Ayurveda Condition: MALA-APRAVRUTIHÂ (KEVALAVATA), (2) ICD-10 Condition:K929||Disease of digestive system, unspecified. Ayurveda Condition: MALA-APRAVRUTIH (KEVALAVATA), |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Shunthyadi Syrup, Reference: Bhavprakash, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 0.8(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Dose is calculated according to weight in Pediatrics. Hence, the dose is 1.6ml/kg/day in 2 divided doses. Dose may vary according to the weight. | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Dhatryadi syrup, Reference: Yog Ratnakar, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 0.8(ml), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: Dose is calculated according to weight in Pediatrics. Hence, the dose is 1.6ml/kg/day in 2 divided doses. Dose may vary according to the weight. |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of preschool age group will be selected irrespective of gender, caste and religion with following criteria-
1. Children fulfilling ROME IV Criteria
(must include at least 2 of the following symptoms)
two or fewer defecations per week
at least 1 episode of faecal incontinence per week
History of retentive posturing or excessive violent stool retention
History of painful or hard bowel movements
Presence of large faecal mass in the rectunm
History of large diameter stools that can obstruct the toilet
2. Abdominal Pain
3. Anorexia |
|
| ExclusionCriteria |
| Details |
K/C/O Other systemic illness like abdominal Kochs
K/C/O Hormonal disease as Hypothyroidism
K/C/O Disorders as Hirschsprungs disease
Children with severe abdominal pain |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Dhatryadi Syrup in the managment of Malavibandha for 7 days. |
7 days where follow up will be on 3rd and 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the adverse effects of Dhatryadi Syrup in the management of Malavibandha if any. |
7 days where follow up will be on 3rd and 7th 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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Malavibandha is not a disease, it’s a symptom. But this symptom has become a major issue in today’s life. According to the Ayurvedic Shabda Kosh, Vibandha means Apravrutti. Hence, Malavibandha can be defined as Mala Apravrutti. MalaVibandha can be correlated with Constipation with its clinical manifestations. Constipation is defined as delay or difficulty in defecation due to hardened faeces present for 2 or more weeks and sufficient to cause significant distress to the patient Vibandha is due to altered food habits, raised fast food culture, changing sleep patterns. improper toilet training, lack of exercise and impact of stressful child. In Mala Vibandh, Anulom Gati of Apan Vayu is obstructed and becomes Pratilom. Therefore, Purish is obstructed in Pakvashaya and further compliactaions such as unsatisfactory bowel emptying, indigestion of food, etc. occurs which leads to deterioration of the health of the child. |