CTRI Number |
CTRI/2025/06/088481 [Registered on: 10/06/2025] Trial Registered Prospectively |
Last Modified On: |
09/06/2025 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Ayurveda Nutraceutical |
Study Design |
Single Arm Study |
Public Title of Study
|
A study to see effect of Chaturbeej jelly candy on abdominal pain during periods in young girls. |
Scientific Title of Study
|
A single arm prospective phase ii clinical study to evaluate the effect of chaturbeej jelly candy (as a neutraceutical product) on abdominal pain in kashtartava w.s.r to primary dysmenorrhea in young girls |
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 Shravani Girish Kulkarni |
Designation |
Professor department of Rachana Sharir |
Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
Address |
OPD no 5 Strirog and Prasuti tantra OPD
Nashik MAHARASHTRA 422003 India |
Phone |
9822173345 |
Fax |
|
Email |
shravanigirishkulkarni@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Shravani Girish Kulkarni |
Designation |
Professor department of Rachana Sharir |
Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
Address |
OPD no 5 Strirog and Prasuti tantra OPD
Nashik MAHARASHTRA 422003 India |
Phone |
9822173345 |
Fax |
|
Email |
shravanigirishkulkarni@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Shravani Girish Kulkarni |
Designation |
Professor department of Rachana Sharir |
Affiliation |
Ayurved Seva Sangh Ayurved Mahavidyala, Ganeshwadi ,Panchavati ,Nashik- 03 |
Address |
OPD no 5 Strirog and Prasuti tantra OPD
Nashik MAHARASHTRA 422003 India |
Phone |
9822173345 |
Fax |
|
Email |
shravanigirishkulkarni@gmail.com |
|
Source of Monetary or Material Support
|
|
Primary Sponsor
|
Name |
Maharshtra University of Health SciencesNashik under the scheme of LTRG |
Address |
Maharshtra University of Health Sciences,Nashik Dindori road Nashik 422004 |
Type of Sponsor |
Other [Health University] |
|
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 Shravani Girish Kulkarni |
Arogyashala Rugnalaya Nashik |
OPD no 5 Strirog Prasutitantra OPD Nashik MAHARASHTRA |
9822173345
shravanigirishkulkarni@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
INSTITUTIONAL ETHICS COMMITTEE Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Abdominal Pain |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: chaturbeej, Reference: bhavprakash nighantu, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 2(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -nil |
|
|
Inclusion Criteria
|
Age From |
13.00 Year(s) |
Age To |
25.00 Year(s) |
Gender |
Female |
Details |
Females in the age group of 13yrs to 25yrs.
Females with abdominal pain during menstruation.
|
|
ExclusionCriteria |
Details |
Females suffering from systemic diseases or any other disease of female reproductive system.
Those females who are not willing to participate in the trial.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction VAS score related to abdominal pain during Kashtartava.(Primary Dysmenorhoea) |
3 days |
|
Secondary Outcome
|
Outcome |
TimePoints |
Improvement in the quality of life in young girls with abdominal pain during Kashtartava.(Primary Dysmenorhoea) |
3 days |
|
Target Sample Size
|
Total Sample Size="150" Sample Size from India="150"
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 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
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
|
Changing
lifestyle and changed diet pattern is causing many harmful effects on health.
Such effects are seen on the female reproductive system also. Primary dysmenorrhea is one of the most
commonly found condition in adolescent girls. Many treatments are available for
this condition. But these medicines are also having side effects. Secondly
young girls refuse to take medication for this as they have to take it every
month. Due to this there is effect on their daily routine. Hence to overcome
this situation Herbal jelly candy will be prepared using Chaturbeej, organic
jaggery and Pectin.
Since
this is a new and attractive dosage form adolescent girls are expected to have
more acceptance to this. The main outcome of this is relief in abdominal pain
caused due to primary dysmenorrhea. 150 subjects will
be selected using simple random sampling method. After screening and consent
they will be included in the study following proper inclusion and exclusion
criteria. The Herbal jell candy which is a neutraceutical product will be given
thrice a day. Each weighing 2
gm and containing 1gm
of Chaturbeej. The duration will be for 3 days during menstruation.
Abdominal
pain will be measured for intensity, duration and nature of pain. VAS will be
used to rate the pain. This will be assessed daily i.e. for three days. Overall
safety will be assessed based on safety parameter. Quality of life of the
adolescent girls who have taken these herbal candy will be assessed. The
term “Kashtartava” means a condition where in Artava is shed with pain. Kashtartava
can be compared with primary
dysmenorrhea based on the symptoms. Kashtartava is a vata and kapha pradhan
vyadhi with mainly predominance of vata dosha. Due to kapha prakopa, kapha
obstructs the srotas and this leads to the dosha prakopa along with pratiloma
gati of apana vayu leading to rajakrichrita . Kashtartava is one of the
artavavaha srotodusti vyadhi in which pain during menstruation is the
predominant feature.
Today
due to changed lifestyle and dietary habits adolescent girls are mainly facing
this problem of abdominal discomfort or pain. And for this they need to take
medication every month during menstruation. But these analgesics and
antispasmodics are having severe side effects on the health of young girls.
They also sometimes refuse to take medicines and hence leaving with such pain
can hamper their daily routine, my it be going to school or colleges or other
routine work. Those girls involved in sports face this as a major hurdle.
Hence
to overcome this issue Herbal jelly candy is an innovative option. These jelly
candies can be made from the drugs which are vatanulomak and vedanashamak.
Pectine can be used as a base for making these jelly candy and organic jaggery
will be used as sweetener. The jelly candy are a chewable sweet which will be
containing herbs useful in relieving abdominal pain in Kashtartava. These
candies can be made available in attractive packaging. Since the dosage form of
the medicine is interesting it can be easily accepted and consumed by the
patients. Secondly they are cost effective as compared to the medicines
available for the same condition in the market .Chaturbeej is mentioned in Bhavaprakash for abdominal
pain. But in this study it will be specifically used in abdominal pain
experienced in Primary dysmennorrhoea. The dosage form mentioned in the
classical texts is churn (powder ) form. But in this study jelly candy will be
prepared using Chaturbeej churn.
This Chaturbeej jelly candy will be prepared using
Pectin , which is a plant extract and mainly derived from citrus fruits. Hence
this is not harmful. There are studies which suggest that pectin is supposed to
have good effects on digestive system. It is also helpful in constipation which
may persist during Primary dysmennorrhoea.
Chaturbeej jelly candy is a new and innovative
palatable dosage form. Jaggery will be added as a sweetener . This will also
help in improving the action of Chaturbeej there by leading to vatanuloman. Due
to the sweet taste it will be easily consumed by young girls.
Chaturbeej contains four drugs which are available in
the Indian kitchen and is used in day
today food prepared at home. Hence this is a neutraceutical option for
abdominal pain without any side effects on body. Chaturbeej is mentioned in Bhavaprakash for abdominal
pain. But in this study it will be specifically used in abdominal pain
experienced in Primary dysmennorrhoea. The dosage form mentioned in the
classical texts is churn (powder ) form. But in this study jelly candy will be
prepared using Chaturbeej churn.
This Chaturbeej jelly candy will be prepared using
Pectin , which is a plant extract and mainly derived from citrus fruits. Hence
this is not harmful. There are studies which suggest that pectin is supposed to
have good effects on digestive system. It is also helpful in constipation which
may persist during Primary dysmennorrhoea.
Chaturbeej jelly candy is a new and innovative
palatable dosage form. Jaggery will be added as a sweetener . This will also
help in improving the action of Chaturbeej there by leading to vatanuloman. Due
to the sweet taste it will be easily consumed by young girls.
Chaturbeej contains four drugs which are available in
the Indian kitchen and is used in day
today food prepared at home. Hence this is a neutraceutical option for
abdominal pain without any side effects on body. |