| 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
|
|
|
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
|
|
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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. |