| CTRI Number |
CTRI/2025/11/096758 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Randomized Controlled Trial to evaluate the efficacy of Draksha syrup in Vibandha in children ( 2-6 years) with reference to
Functional Constipation. |
|
Scientific Title of Study
|
Randomized Controlled Trial to evaluate the efficacy of Draksha syrup in Vibandha in children ( 2-6 years) with reference to
Functional Constipation. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ARBAZ ISAQ SHAIKH |
| Designation |
PG Resident |
| Affiliation |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON |
| Address |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MH
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MH
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
842131731 |
| Fax |
|
| Email |
arbaz_shaikh49@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Dhanwade |
| Designation |
Associate Professor |
| Affiliation |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON |
| Address |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MH
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MH
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7620055444 |
| Fax |
|
| Email |
dhanwaderavi7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ravindra Dhanwade |
| Designation |
Associate Professor |
| Affiliation |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON |
| Address |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MH
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MH
Ahmadnagar
MAHARASHTRA
414502
India |
| Phone |
7620055444 |
| Fax |
|
| Email |
dhanwaderavi7@gmail.com |
|
|
Source of Monetary or Material Support
|
| PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MAHARASHTRA INDIA - 414502 |
|
|
Primary Sponsor
|
| Name |
Dr ARBAZ ISAQ SHAIKH |
| Address |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON |
| 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 |
| Dr ARBAZ ISAQ SHAIKH |
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON |
Pediatric OPD
PMTs AYURVED COLLEGE AND SHRI EKNATH AYURVED RUGNALYA SHEVGAON
KHANDOBANAGAR, AKHEGAON ROAD SHEVGAON, DIST. AHMEDNAGAR MH
Ahmadnagar
MAHARASHTRA |
8421317317
arbaz_shaikh49@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe PMTs Ayurved College, Shevgaon |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K590||Constipation. Ayurveda Condition: VIBANDHA, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: LACTULOSE SYRUP , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: DRAKSHA SYRUP , Reference: Bhavprakash Nighantu , Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 05(ml), Frequency: hs, Bhaishajya Kal: Adhobhakta, Duration: 07 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient age group 2-6 years irrespective of sex, religion and economical status
2.Children fulfilling the ROM III criteria30 or patient presenting sign and symptoms of vibandha.
3.Parents/ Guardians of the child willing to participate in clinical trial/study with written consent. |
|
| ExclusionCriteria |
| Details |
1. Patients having Constipation due to severe illness related to Anorectal Conditions and organic disorders like Hirschsprung disease.
2. Patients with Rectal Prolapse, IBD, Malignancy, endocrinal disease etc or any other systemic illness.
3. Patient on any other long-term medications.
4. Patient known case of Neuromuscular disease like cerebral palsy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
DRAKSHA SYRUP is effective in Vibhandha in children within 7 days
That is, the main efficacy outcome used for sample size estimation is the mean change in spontaneous bowel movements per week from baseline to day 7. |
Follow up will be done on 0 , 3 and 7 day and outcome will be recorded. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LACTULOSE SYRUP is effective in Vibhandha in children |
Patient will be assessed on 0, 3 & 7 th day |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
13/11/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sushrutacharya while explaining the digestive system of our body cited that the process of digestion occurs over time, drawing downward (the waste products), assisted by the wind (air or vata). It governs the excretion of feces, urine, semen, menstrual blood, and other substances. When aggravated, it causes severe diseases related to the bladder, rectum, and other associated areas. In Ayurveda, constipation is known as Vibandha or Badhapurish, presenting as a common issue in childhood that often causes considerable parental concern. It is characterized by difficulty in passing stools, typically associated with dry and hard stools and infrequent bowel movements, most prevalent among children aged 2 to 6 years. The causes of Vibandha in Ayurvedic perspective include factors like breastfeeding from a mother with vitiated Vata (Vata Dushita Stanya Sevana), parasitic infections (Krimi), and suppression of natural urges (Parish Vega-Vidharana), which disrupt normal digestive functions1. These disturbances lead to the accumulation of Ama (undigested or improperly digested food substances), aggravation of the Vata dosha (responsible for movement), and weakening of digestive fire (Jatharagni Mandya), culminating in the manifestation of constipation.2 If left untreated, Vibandha can result in complications such as vomiting (Chardana), depletion of bodily fluids (Rasa Kshaya), and emaciation (Karshya). Prevention strategies focus on dietary adjustments, including a high-fiber diet and adequate fluid intake, alongside promoting regular physical activity and timely bowel habits. Treatment of Vibandha involves a holistic approach in Ayurveda, aiming to eliminate causative factors (Nidan Parivarjana), enhance digestive fire (Dipan), aid in the digestion of toxins (Pachan), normalize Vata movement downward (Anulomana), and facilitate stool expulsion through procedures like Bhedana and Rechana3. Ayurveda views constipation not merely as a local issue but as a reflection of overall imbalance in the body. This perspective allows for treatments that address the root cause of Vibandha, promoting long-term health without adverse side effects. Additionally, Ayurvedic remedies are considered safe and effective alternatives for managing constipation, particularly when gentle, natural approaches are preferred. The global impact of childhood constipation is frequently underestimated, largely due to limited data availability within this age group4. Epidemiological studies use various definitions, ranging from the established Rome criteria to parent-reported proxies. A recent systematic review in pediatric populations indicated constipation prevalence ranging widely from 4% to 29.6%5. This variation in prevalence can be attributed not only to differing definitions but also to variations in symptom duration required for diagnosis, age distributions of study participants, and methods of data collection. Chronic constipation in children is when a child experiences two or more of the following symptoms for at least two months: fewer than three bowel movements per week, accidental leaking of stool more than once a week, stool getting stuck in the rectum, passing stool so large that it clogs the toilet, holding in stool on purpose, and pain during bowel movements. About 60% of children with constipation may experience overflow incontinence, where stool leaks out due to a build-up in the rectum. Most cases of constipation in children are due to holding in stool,either on purpose or without realizing it. About 2% of healthy primary school children have this condition, with boys being affected up to four times more often than girls. |