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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  
nil 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Abdominal Pain  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(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.

 
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