| CTRI Number |
CTRI/2025/05/086930 [Registered on: 14/05/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| 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
|
Ayurvedic management of functional constipation in children |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Shatahvadi Niruha Basti Over Pippalyadi Taila Matrabasti In The Management Of Vibandha(Funtional 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 |
DR KALLAGODI LAKSHMIDEVI |
| Designation |
PG SCHOLAR |
| Affiliation |
Shree jagadguru gavisiddheswara ayurvedic medical college and Hospital, Koppal |
| Address |
OPD no 13, Dept of Kaumarabhritya, Shree jagadguru gavisiddheswara ayurvedic medical college post graduate studies and research center, Gavimat campus, Koppal Gavimat campus,koppal Koppal KARNATAKA 583231 India |
| Phone |
9886594135 |
| Fax |
|
| Email |
klakshmidevi93981@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR SURYANARAYANA MUDADLA |
| Designation |
Head of the Department |
| Affiliation |
Shree jagadguru gavisiddheswara ayurvedic medical college and Hospital, Koppal |
| Address |
OPD no 13, Dept of Kaumarabhritya, Shree jagadguru gavisiddheswara ayurvedic medical college post graduate studies and research center, Gavimat campus, Koppal Gavimat campus,koppal Koppal KARNATAKA 583231 India |
| Phone |
7411642191 |
| Fax |
|
| Email |
surya83.m@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DR SURYANARAYANA MUDADLA |
| Designation |
Head of the Department |
| Affiliation |
Shree jagadguru gavisiddheswara ayurvedic medical college and Hospital, Koppal |
| Address |
OPD no 13, Dept of Kaumarabhritya, Shree jagadguru gavisiddheswara ayurvedic medical college post graduate studies and research center, Gavimat campus, Koppal Gavimat campus,koppal Koppal KARNATAKA 583231 India |
| Phone |
7411642191 |
| Fax |
|
| Email |
surya83.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shree Jagadguru Gavisiddheshwara Ayurvedic medical ollege and hospital, Koppal, Gavimat campus, Koppal(D), 583231 |
|
|
Primary Sponsor
|
| Name |
Dr Kallagodi Lakshmidevi |
| Address |
PG Scholar, Dept of Kaumarabhritya, SJGAMC Koppal |
| 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 Kallagodi Lakshmidevi |
Shree Jagadguru Gavisiddheswara Ayurvedic medical college and Hospital, Koppal |
OPD No 13, Dept of Kaumarbhritya Koppal KARNATAKA |
9886594135
klakshmidevi93981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe |
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 | Intervention Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Kashyapa Samhitha, Procedure details: Position- left lateral position with flexing the right leg over fully extended left leg
time of administration- Prathakala rikta koshta
The anus and the enema nozzle are lubricated with oil
after removing the air bubble, 1/4 of enema nozzle is introduced in the anus slowly and rightly following the curves of the spinal column without shaking or trembling.
With a single act of compression on the receptacle, inject the content and then gradually withdraw the nozzle of the tube from the anus. ) (1) Medicine Name: Shatahvadi Kashaya and Shathaavadi Churna , Reference: Kashyapa Samhita Khila Sthana , Route: Rectal, Dosage Form: Kwatha/Kashaya, Dose: 300(ml), Frequency: od, Duration: 7 Days | | 2 | Comparator Arm | Procedure | - | bastikarma/vastikarma, बस्तिकर्म/वस्तिकर्म | (Procedure Reference: Kashyapa Samhitha, Procedure details: Position- left lateral position with flexing the right leg over fully extended left leg
time of administration- Prathakala
The anus and the enema nozzle are lubricated with oil
after removing the air bubble, 1/4 of enema nozzle is introduced in the anus slowly and rightly following the curves of the spinal column without shaking or trembling.
With a single act of compression on the receptacle, inject the content and then gradually withdraw the nozzle of the tube from the anus.) (1) Medicine Name: Pippalyadi Taila , Reference: Ashtanga Hridaya Chikitsa Sthana , Route: Rectal, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1.The children of either gender between the age group of 1-10 years fulfilling the diagnostic criteria of Vibandha.
2. Children whose parents are willing to participate them in the study by giving informed parent consent |
|
| ExclusionCriteria |
| Details |
Children with organic causes like Hirschsprung’s disease, inflammatory bowel disease, anatomical malformations of anal canal and hypothyroidism are excluded from the study. |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Shatahvadi niruha basti has superior effect over Pippalyadi taila matrabasti in the management of Vibandha (functional constipation) |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increased appetite |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2025 |
| 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="3" 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
|
Functional constipation is characterized by infrequent bowel movements, hard and/or large stools, painful defecation and fecal incontinence and is often accompanied by abdominal pain. It is one of the lifestyle disorders caused due to the suppression of urges and irregular eating habits. The prevalence of childhood constipation in general population varies widely ranging from 0.7% to 29.6% and a mean female to male ratio of 2.1:11. It accounts for 3% of visits to general paediatric clinics and accounts for up-to 25% of visits to paediatric gastroenterologist. It is commonly seen among toddlers and pre-school children2 and it is more frequent when fibre dietary food and liquid diet intake are restricted. Though functional constipation is a gastro-intestinal disease, it also have the impact on the general health of a child, if not treated at the right time, it may lead to distress for the child further leading to recurrent discomfort in abdomen, reduced appetite, and the child even fears to defecate due to the pain experienced while passing hard stools. So, it is important that the disease is treated at the beginning stage itself before it leads to further complications like fissures, rectal prolapse and haemorrhoids. Main line of treatment according to modern science is considered to be use of laxatives like Polyethylene glycol, Lactulose, Magnesium Hydroxide etc and enemas like Bisacodyl, Sodium docustate which might temporarily relieve the condition and might reoccur later. Vibandha is one of the Vataja nanatmaja vikara mentioned in ayurveda which is analogous to Constipation. It is caused due to Dusti of Apanavayu, Annavaha and Purishavaha srotas dusti. Apanavayu is one among the 5 types of Vata and the function of Apanavayu is Nishkramana of mala, mutra, shukra, arthava and garbha. Vibandha is frequently mentioned in ayurveda but no dedicated chapter is available for the same. It is mentioned as a Nidana, Poorvaroopa, Roopa, Upadrava and as a Panchakarma vyapad in various contexts in the classical texts and is seen as one of the symptoms in udavartha, anaha, adhmana, arsha. So far few researches have been done on constipation in children by administering internal medications like Haritaki, Trivruthadi avalehya, shuntyadi syrup etc. but there is a chance of getting acquainted to internal medications over the period of time. Hence, it is difficult to manage the condition alone with oral medications. For Vata vyadhi, Basti is one of the treatment mentioned in ayurveda and it is said as ardha chikitsa. But, basti is not been used frequently and not a single study on shodhana basti is available in existing data. Hence, Shodhana basti has been taken for present study. As alone Snehabasti can also relieve the condition but it may not do shodhana, hence Shodhana basti is selected here for the present study. Shatahvadi niruha basti mentioned in Kashyapa Samhita consist of Shatahva, Pippali, Kusta, Vacha, Devadaru, Poothika, Harenu, Bilva and Madanaphala and is said to relieve conditions like shoola, anaha and Vibandha. Hence present study has been taken to evaluate the effect of Shatahvadi niruha basti over Pippalyadi taila matrabasti in the management of Vibandha. |