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
- Conditions
- Primary dysmenorrhea. Ayurveda Condition: UDAVARTINI,
- Registration Number
- CTRI/2025/05/087616
- Lead Sponsor
- National Institute of Ayurveda
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 40
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method NRS – Scale: Numeric Rating Scale for Dysmenorrhea 60 days
- Secondary Outcome Measures
Name Time Method 1. VMSS scale: Verbal Multidimensional Scoring System 2. Changes in Quality of life Scale for menstrual disorders
Trial Locations
- Locations (1)
NATIONAL INSTITUTE OF AYURVEDA
🇮🇳Jaipur, RAJASTHAN, India
NATIONAL INSTITUTE OF AYURVEDA🇮🇳Jaipur, RAJASTHAN, IndiaDR Rajshree GanoliaPrincipal investigator9530449121rajshreeganolia3851@gmail.com