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CTRI Number  CTRI/2025/05/087616 [Registered on: 26/05/2025] Trial Registered Prospectively
Last Modified On: 09/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical study to evaluate the effect of Hingwadi churna and eranda bhrista haritaki churna along with trivrit taila matra basti in the condition of Primary dysmenorrhea  
Scientific Title of Study   A RANDOMIZED COMPARATIVE CLINICAL TRIAL TO EVALUATE THE EFFICACY OF HINGWADI CHURNA AND ERANDA BHRISTA HARITAKI CHURNA ALONG WITH TRIVRIT TAILA MATRA BASTI IN THE MANAGEMENT OF UDAVARTA YONI VYAPADA W.S.R TO PRIMARY DYSMENORRHEA  
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 Rajshree Ganolia 
Designation  Post graduate scholar Department of Prasuti tantra and Stri roga 
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9530449121  
Fax    
Email  rajshreeganolia3851@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr HETAL H DAVE 
Designation  ASSOCIATE PROFFESOR 
Affiliation  National Institute of Ayurveda 
Address  DEPARTMENT OF PRASUTI TANTRA Evam STRI ROGA National Institute of Ayurveda,deemed to be university ,jorawar singh gate,amer road,jaipur, rajasthan 302002 india

Jaipur
RAJASTHAN
302002
India 
Phone  9251758867  
Fax    
Email  hetaldave2406@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rajshree Ganolia 
Designation  Post graduate scholar Department of Prasuti tantra and Stri roga 
Affiliation  National Institute of Ayurveda 
Address  Department of Prasuti tantra and Stri roga 3rd floor National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9530449121  
Fax    
Email  rajshreeganolia3851@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India  
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  National Institute of Ayurveda Jorawarsingh gate Amer road Jaipur Rajasthan 302002 India  
Type of Sponsor  Research institution 
 
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 Rajshree Ganolia  NATIONAL INSTITUTE OF AYURVEDA  OPD Room number 26 and 27 and IPD of Department of Prasuti tantra and stri roga
Jaipur
RAJASTHAN 		 9530449121

rajshreeganolia3851@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUE OF AYURVEDA   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:N944||Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Trivrit Taila Matra basti explained by Acharya Charak in Charak Chikitsa 30 Shloka no 110 and 111., Procedure details: 60 ml for 7 days just after meal starting from 18th day of menstrual cycle for 2 consecutive menstrual cycles))
(1) Medicine Name: Eranda Bhrista Haritaki churna , Reference: Eranda & Haritaki as explained Erandamoola is Vrisya Vata Haranam in Charaka Sutra 25 shloka no. 40 .Haritaki which is dosha Anulomani Sarvaroga Prasamni Charaka Chikitsa 1 shloka no.32, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 60 Days
2Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Trivrit Taila Matra basti explained by Acharya Charak in Charak Chikitsa 30 Shloka no 110 and 111. , Procedure details: 60 ml for 7 days just after meal starting from 18th day of menstrual cycle for 2 consecutive menstrual cycles)
(1) Medicine Name: Hingwadi Churna, Reference: mentioned in Chakradutta written by Shri Chakrapani Dutt with commentary Bhavarth Sandipani by Shri Jagdishwar Prasad Trpathi, Chaukambha Sanskrit series office edition 2008, Chikitsasthan,chapter 26 on shloka Chikitsa Adhyaya , shloka no. 72 , page no. 243.Pleehashoolaapaham Rajah. , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Duration: 60 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  Patients with chief complaint of pain during menses along with associated symptoms
Patients who have menstrual pain score more than grade I according to verbal multidimensional scoring system VMSS
Patients who had regular menstrual cycles with normal or scanty flow of 26 to 35 days in the last 2 months
Patients in age group of 18 to 30 years
Patients with H/o using analgesics during menses
Patient willing to give voluntary informed consent for the study
 
 
ExclusionCriteria 
Details  1.The patient suffering from any severe K/C/O systemic or autoimmune disorders, specially those who are mentioned as Asadhya Vyadhi as per clinical text of Ayurveda will be excluded.
2.Subjects having organic pathology of uterus and adnexa like Fibroid uterus, polyp.
3.Patients with K/C/O anatomical defects of reproductive tract, pelvic inflammatory disease, chronic leucorrhea and thyroid dysfunction, DM 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
NRS – Scale: Numeric Rating Scale for Dysmenorrhea  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. VMSS scale: Verbal Multidimensional Scoring System
2. Changes in Quality of life Scale for menstrual disorders
3. Prevalence of anovulation in different types of prakriti 		 60 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 2 
Date of First Enrollment (India)   02/11/2025 
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="0"
Months="2"
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  

NEED OF THE STUDY

Udavarta Yonivyapad is one of the common Gynaecological disorders, which affects a large section of female population. Conventional allopathic medical treatment may relieve symptoms of dysmenorrhea but it does not address the root cause of the problem. In modern system of medicine dysmenorrhea is treated by hormones, non-steroidal anti-inflammatory, anti-spasmodic, analgesic drugs etc. Long term use of these drugs may cause side effects like hepatotoxicity, nephrotoxicity, headache, dizziness, vertigo, depression, skin rashes etc. So to avoid these complications, an attempt is made to find solution to address root cause of this problem. There is a great scope of research with long lasting effect, to treat the entire feature complex with single regimen and find out the treatment for the underlying pathology from Ayurveda for the management of Udavarta.

 

RATIONALITY OF TRIAL DRUG

The Hingwadi Churna contains Hingu, Sunthi, Maricha, Pippali, Kustha, Yava Kshara, Saindhav lavana as mentioned in Chakradutta written by Shri Chakrapani Dutt with commentary Bhavarth Sandipani by Shri Jagdishwar Prasad Trpathi, Chaukambha Sanskrit series office edition 2008, Chikitsasthan,chapter 26 on shloka Chikitsa Adhyaya , shloka no. 72 , page no. 243.Pleehashoolaapaham Rajah.

Trivrit Taila Matra basti explained by Acharya Charak in Charak Chikitsa 30 Shloka no 110 and 111.

Hingu is having Laghu, Snigdha, Tikshna Guna, Katu Rasa, katu Vipaka and Ushna Virya, Stri-Pushpa Janana, Deepana, Pachana properties.

Shunthi is Laghu and Snigdha in Guna, Katu Rasa, Madhura Vipaka and Ushna Virya.It has having Shula Prashamana, and Deepana properties.

Kustha is Laghu, Ruksha, Tiksna,

Yava kshara is Tikshna, Laghu, Ruksha, Sukshma, Saindhava Lavana is Laghu, Snigdha.

Matulunga is Tikshna which is used as Bhavna Dravya .

Eranda Bhrista Haritaki churna has Eranda & Haritaki as explained Erandamoola is Vrisya Vata Haranam in Charaka Sutra 25 shloka no. 40 .Haritaki which is dosha Anulomani Sarvaroga Prasamni Charaka Chikitsa 1 shloka no.32.

Pippali is Laghu,Snigdha,Tikshna in Guna, Katurasa, Madhura Vipaka and Anushna In virya.It is considered in Shula Prashamana Gana in Charak Samhita.

Maricha is Laghu,Teekshna in Guna, Katu Rasa, Madhura Vipaaka and Ushna Virya. According to Bhavaprakasha it has got Shulaprashamana and Deepana properties.

Hence it is a good combination of Shula Prashamana drugs and indicated for Anuloma Gati of Vayu. In Udavarta Urdhva Gati of Vayu is causing the pain during menses, this drug thought to be an ideal choice to explore clinically in the management of Udavarta Yonivyapad, though there is no direct indication is there for the same.

RESEARCH QUESTIONS:  Is there any difference in the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yonivyapad with special reference to Primary dysmenorrhea?

HYPOTHESIS:

 Null hypothesis [H0]:

There is no difference in the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yonivyapad with special reference to Primary dysmenorrhea.

 Alternative Hypothesis [HA]:

There is difference in the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yonivyapad with special reference to Primary dysmenorrhea.

 

AIM:

To evaluate the efficacy of Hingwadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yoni Vyapada with special reference to Primary dysmenorrhea

 

OBJECTIVE:

Primary objective:

To evaluate and compare the clinical efficacy of Hingvadi Churna and Eranda Bhrista Haritaki Churna along with Trivrit Taila Matra Basti in the management of Udavarta Yoni Vyapada with special reference to Primary dysmenorrhea.

 Secondary objective:

i.To assess improvement in the quality of life.

ii.Distribution patterns in Udavarta Yoni Vyapada in different types of prakriti.

 
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