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CTRI Number  CTRI/2026/03/106572 [Registered on: 19/03/2026] Trial Registered Prospectively
Last Modified On: 18/03/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Clinical study conducted on women suffering from Endometriosis related painful menstruation to evaluate how well Shoolahara Kashaya , Yavadi Utkarika and their combined use help in reducing pain during periods  
Scientific Title of Study   A RANDOMISED OPEN LABELLED COMPARATIVE CLINICAL STUDY ON THE EFFICACY OF SHOOLAHARA KASHAYA AND YAVADI UTKARIKA AS A SINGLE THERAPIES AND IN COMBINATION ON PAIN MANAGEMENT IN ENDOMETRIOSIS RELATED TO SECONDARY 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  DrApurva Ajit Dongare  
Designation  PG Scholar  
Affiliation  Sri Sri College Of Ayurvedic Science and Research Hospital , Bangalore  
Address  Room no-10 Prasooti Tantra and Stree Roga OPD,Sri Sri College Of Ayurvedic Science and Research Hospital Bangalore
Room no-10 Prasooti Tantra and Stree Roga OPD,Sri Sri College Of Ayurvedic Science and Research Hospital Bangalore
Bangalore
KARNATAKA
560082
India 
Phone  9112178371  
Fax    
Email  apurvadongare11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shruti Patil 
Designation  Associate Professor  
Affiliation  Sri Sri College Of Ayurvedic Science and Research Hospital , Bangalore  
Address  Room no-10 Prasooti Tantra and Stree Roga OPD,Sri Sri College Of Ayurvedic Science and Research Hospital Bangalore
Room no-10 Prasooti Tantra and Stree Roga OPD,Sri Sri College Of Ayurvedic Science and Research Hospital Bangalore
Bangalore
KARNATAKA
560082
India 
Phone  9886269111  
Fax    
Email  shrutivinsun@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shruti Patil 
Designation  Associate Professor  
Affiliation  Sri Sri College Of Ayurvedic Science and Research Hospital , Bangalore  
Address  Room no-10 Prasooti Tantra and Stree Roga OPD,Sri Sri College Of Ayurvedic Science and Research Hospital Bangalore
Room no-10 Prasooti Tantra and Stree Roga OPD,Sri Sri College Of Ayurvedic Science and Research Hospital Bangalore
Bangalore
KARNATAKA
560082
India 
Phone  9886269111  
Fax    
Email  shrutivinsun@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri College of Ayurvedic Science and Research Hospital, 21st K.M,Knakapura Road,Udayapura,Bangalore,Karnataka 560082 
 
Primary Sponsor  
Name  Dr. Apurva Ajit Dongare 
Address  Sri Sri College of Ayurvedic Science and Research Hospital 21st K.M Knakapura Road,Udayapura,Bangalore,Karnataka 560082 
Type of Sponsor  Other [Self] 
 
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 
DrApurva Ajit Dongare   Sri Sri College Of Ayurvedic and Research Hospital , Bangalore  Room no 10,Prasooti Tantra and Stree Roga OPD,Sri Sri College of Ayurvedic science and Research Hospital ,21st K.M Kanakapura Road , Udayapura Bangalore, Karnataka
Bangalore
KARNATAKA 
9112178372

apurvadongare11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Sri Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N711||Chronic inflammatory disease of uterus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Combined-Yavadi Utkarika + Shoolahara Kashaya   Yavadi Utkarika Drugs are mentioned hey are Yava, Godhuma,Kinwa,Kushta, Shatpushpa,Srahyava,Priyangu, Bala , Akhukarni. Utkarika is prepared by taking dried up drugs. After complete drying the drugs mentioned has to be pounded separately and make it into fine powder. The drugs mentioned are Yava, Godhuma,Kushta,Shatpushpa,Shrayavha,Priyangu,Bala,Akhukarni.Later all the drugs are to be mixed homogeneously and made into a packet of 150g / day for 1 participant.And cooked rice Kinwa will be prepared in batches and will be given to the participants in bottles (amber bottles). Shoolahara Kashaya drugs are mentioned, They are Nirgundi , Eranda, Koranda,Gokshura , Dwi Punarnava, Panchkola, Abhaya, Shigru Kulattha Preparation of Shoolahara Kashaya-The drugs that are to go into the composition of the Shoolahara Kwatha Churna are taken and cleaned.They are perfectly dried and powdered separately and then mixed. The powders should be coarse.Pounding the drugs in mortar until coarsely powdered is sufficient, because the Kwatha Churna should not be a very fine powder, the decoction is not easily filtered into a clear liquid, this is due to these fine particles, passing through the filter. The drugs mentioned are Nirgundi, Eranda, Koranda, Gokshura, Dwi Punarnava, Panchkola , Abhaya Shigru, Kulattha. After pounding Dravyas and making it into coarse powder (Yavakuta) 1 gram of each Dravya weighed as per formula and then mixed well.The Kwatha is been prepared by boiling 1 part of Kwatha Choorna with 16 parts of water in open vessel on mild fire till it reduces to 1/8th of original quantity. ie 14 grams of Kwatha Choorna boiled in 224 ml of water reduced to 48ml and filter Kashaya into vessel. To increase Shoolahara Kashaya shelf life we will be adding preservatives in Kashaya. Then the Kashaya will be packed in bottles and will be given to participant 
Intervention  Shoolahara Kashaya   In Sahasrayogam, Kashaya prakarana, Formulation no.44 Shoolahara Kashaya drugs are mentioned, They are Nirgundi , Eranda, Koranda,Gokshura , Dwi Punarnava, Panchkola, Abhaya, Shigru Kulattha Preparation of Shoolahara Kashaya-The drugs that are to go into the composition of the Shoolahara Kwatha Churna are taken and cleaned.They are perfectly dried and powdered separately and then mixed. The powders should be coarse.Pounding the drugs in mortar until coarsely powdered is sufficient, because the Kwatha Churna should not be a very fine powder, the decoction is not easily filtered into a clear liquid, this is due to these fine particles, passing through the filter. The drugs mentioned are Nirgundi, Eranda, Koranda, Gokshura, Dwi Punarnava, Panchkola , Abhaya Shigru, Kulattha. After pounding Dravyas and making it into coarse powder (Yavakuta) 1 gram of each Dravya weighed as per formula and then mixed well.The Kwatha is been prepared by boiling 1 part of Kwatha Choorna with 16 parts of water in open vessel on mild fire till it reduces to 1/8th of original quantity. ie 14 grams of Kwatha Choorna boiled in 224 ml of water reduced to 48ml and filter Kashaya into vessel. To increase Shoolahara Kashaya shelf life we will be adding preservatives in Kashaya. Then the Kashaya will be packed in bottles and will be given to participant  
Intervention  Yavadi Utkarika   In Ashtang Sangraha Uttarasthana Adhyaya 39 Guhyaroga Pratishedha Shloka no 41-42. Yavadi Utkarika Drugs are mentioned They are Yava,, Godhuma ,Kinwa , Kushta , Shatpushpa, Srahyava , Priyangu, Bala , Akhukarni. Utkarika is prepared by taking dried up drugs. After complete drying the drugs mentioned has to be pounded separately and make it into fine powder. The drugs mentioned are Yava, Godhuma,Kushta,Shatpushpa,Shrayavha,Priyangu,Bala,Akhukarni.Later all the drugs are to be mixed homogeneously and made into a packet of 150g / day for 1 participant.And cooked rice Kinwa will be prepared in batches and will be given to the participants in bottles (amber bottles). 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  1.Women of reproductive age group 20-50 years.
2.Participant clinically diagnosed with Endometriosis meeting one of the following criteria (confirmed by pelvic and rectal examination or ultrasound or laparoscopy).
3.Participant with any classical symptoms of secondary dysmenorrhea associated with Endometriosis.
4.History of Secondary dysmenorrhea with diagnosed Endometriosis
5.Regular menstrual cycles.
6.Participants with mild, moderate and severe pain based on NRS scoring.
7.Participant willing for trial will be selected and willing to participate in follow-up 
 
ExclusionCriteria 
Details  1.Participant diagnosed with Primary dysmenorrhea without any underlying pathology
2.Participant diagnosed with other pelvic pathologies like, uterine fibroids (Leiomyomas), PID, or malignancy of reproductive organs other than Endometriosis
3.Participant with chronic systemic diseases such as hypertension, uncontrolled diabetes, renal failure,Thyroid.
4.Participant with condition associated with the absence of regular menses Polycystic-ovarian syndrome, pregnant women and Lactating women.
5.Participant with an intrauterine device (IUD) or History of metallic implants,history of metallic injury.
6.Participants with less than 6 months of postpartum phase, post-abortion, or post-pregnancy at the time of entry into the trial.
7.Participant with unexplained irregular uterine bleeding.
8.Participant on recent hormonal therapy
9.Participant who is not willing for trial and not willing to participate in follow-up.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1.The efficacy of both Shoolahara Kashaya and Yavadi Utkarika will be established in the management of Secondary dysmenorrhea w.r.t. Pain management in Endometriosis .
2.The efficacy of Shoolahara Kashaya will be established in the management of Secondary dysmenorrhea w.r.t. Pain management in Endometriosis .
3.The efficacy of Yavadi Utkarika will be established in the management of Secondary dysmenorrhea w.r.t. Pain management in Endometriosis
4.Significant decrease in the symptoms of Secondary dysmenorrhea w.r.t. Pain management in Endometriosis will be assessed based on subjective and objective parameters related to disease.

 
Group A
Pre assessment 0th day (5-7 days before menstrual
cycle)
1st assessment -After 1ST Menstrual cycle
2nd assessment - After 2nd Menstrual cycle
Follow up (On trial without medicines Assessment) -After 3rd Menstrual cycle

Group B
Pre assessment 0th day (5-7 days before menstrual
cycle)
1st assessment -After 1ST Menstrual cycle
2nd assessment - After 2nd Menstrual cycle
Follow up (On trial without medicines Assessment) -After 3rd Menstrual cycle

Group C
Pre assessment 0th day (5-7 days before menstrual
cycle)
1st assessment -After 1ST Menstrual cycle
2nd assessment - After 2nd Menstrual cycle
Follow up (On trial without medicines Assessment) -After 3rd Menstrual cycle 
 
Secondary Outcome  
Outcome  TimePoints 
1.Improvement in menstrual cycle regularity
2.Reduction in symptoms of mood disturbance
3.Improvement in quality of life
4.Improvement in menstrual cycle characteristics  
Group A
Pre assessment 0th day (5-7 days before menstrual
cycle)
1st assessment -After 1ST Menstrual cycle
2nd assessment - After 2nd Menstrual cycle
Follow up (On trial without medicines Assessment) -After 3rd Menstrual cycle

Group B
Pre assessment 0th day (5-7 days before menstrual
cycle)
1st assessment -After 1ST Menstrual cycle
2nd assessment - After 2nd Menstrual cycle
Follow up (On trial without medicines Assessment) -After 3rd Menstrual cycle

Group C
Pre assessment 0th day (5-7 days before menstrual
cycle)
1st assessment -After 1ST Menstrual cycle
2nd assessment - After 2nd Menstrual cycle
Follow up (On trial without medicines Assessment) -After 3rd Menstrual cycle 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   02/04/2026 
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="1"
Months="6"
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  

Dysmenorrhea is a common gynecological condition characterized by painful menstruation severe enough to interfere with daily activities. It is classified into primary dysmenorrhea (without pelvic pathology) and secondary dysmenorrhea, which occurs due to underlying pelvic pathology, most commonly endometriosis.

Endometriosis is defined as the presence of functioning endometrial glands and stroma outside the uterine cavity. It affects approximately 10–15% of reproductive-age women and up to 70% of women with chronic pelvic pain. Its prevalence is higher among infertile women (30–40%). The rising prevalence is attributed both to lifestyle factors (delayed marriage, postponed conception, small family norms) and improved diagnostic techniques like laparoscopy.

Pain severity in endometriosis does not always correlate with disease stage, indicating complex pain mechanisms. Despite hormonal therapy and surgical management, many women continue to suffer from persistent pain, reduced quality of life, anxiety, and infertility, highlighting the need for alternative therapeutic approaches.

In Ayurveda, secondary dysmenorrhea can be correlated with Kashtartava, Vatiki Yonivyapada, and Udavartini Yonivyapada. Pain (Shoola) is primarily due to Vata vitiation, particularly Apana Vayu dushti. The principle of management focuses on Vatanulomana to maintain normal Artava Pravruti . Classical references from Acharya Charaka, Sushruta, and Vagbhata emphasize Vata as the key etiological factor in Yoni Roga.

The present study aims to evaluate the efficacy of Shoolahara Kashaya (oral) and Yavadi Utkarika (local application) in managing endometriosis-related secondary dysmenorrhea, addressing the current gap in Ayurveda-based, non-hormonal, non-invasive pain management strategies.

 
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