| CTRI Number |
CTRI/2025/08/092557 [Registered on: 06/08/2025] Trial Registered Prospectively |
| Last Modified On: |
06/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Randomized comparative clinical study of efficacy of guda pippalimoola churna and tagara churna in anidra with special reference to primary insomnia |
|
Scientific Title of Study
|
Randomized comparative clinical study of efficacy of Guda Pippalimoola Churna and Tagara Churna in Anidra with special reference to Primary Insomnia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aditi Sandip Suvase |
| Designation |
PG Scholar |
| Affiliation |
SSTAC Sangamner |
| Address |
Department Of Kayachikitsa SSTAC Sangamner
Ahmadnagar
MAHARASHTRA
422605
India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
8862041371 |
| Fax |
|
| Email |
aditisuvase1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pallavi Muneshwar |
| Designation |
Associate Professor of Kayachikitsa Department |
| Affiliation |
SSTAC Sangamner |
| Address |
Department of Kayachikitsa SSTAC Sangamner
Ahmadnagar
MAHARASHTRA
422605
India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9975229605 |
| Fax |
|
| Email |
pallavi.eml@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pallavi Muneshwar |
| Designation |
Associate Professor of Kayachikitsa Department |
| Affiliation |
SSTAC Sangamner |
| Address |
Department of Kayachikitsa
SSTAC Sangamner
Ahmadnagar
MAHARASHTRA
422605
India
Ahmadnagar
MAHARASHTRA
422605
India |
| Phone |
9975229605 |
| Fax |
|
| Email |
pallavi.eml@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Kayachikitsa SSTAC Sangamner
Ahmadnagar
Maharashtra
422605
India |
|
|
Primary Sponsor
|
| Name |
Aditi Sandip Suvase |
| Address |
Department of Kayachikitsa SSTAC Sangamner
Ahmadnagar
Maharashtra
422605
India |
| Type of Sponsor |
Other [Own Research Study ] |
|
|
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 |
| Aditi Sandip Suvase |
Sangam Sevabhavi Trust Ayurved Mahavidyalaya Sangamner |
OPD Division,Ground floor,Room No 5,Kayachikitsa OPD
Ahmadnagar
MAHARASHTRA |
8862041371
aditisuvase1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee SSTAC |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G00-G99||Diseases of the nervous system. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Tagara Churna , Reference: Kaiyadeva Nighantu , Route: Oral, Dosage Form: Churna/ Powder, Dose: 1(g), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: Yes, Route: -Koshnajala, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Intervention Arm | Drug | Classical | | | | 3 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Guda Pippalimoola Churna , Reference: Bhavaprakash Madhyam Khanda , Route: Oral, Dosage Form: Churna/ Powder, Dose: 0.5(g), Frequency: hs, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: 28 Days, Reference: Yes, Route: -Koshnajala, Dosage Form: Churna/ Powder, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: |
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Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient whose informed written consent has been taken
2.Patients of age group 20-60 years
3. Patients suffering from sign and symptoms of Anidra such as jrumbha,tandra,angamarda,shirogaurav,smritidourbalya,manodourbalya
4. Patients having Insomnia Severity Index more than 7
5. Patients who are suffering from difficulty to initiate or maintaing sleep or non restorative sleep for at least 1 month i.e.primary insomnia
6. Patients who are suffering from negative condition to sleep environment i.e.psychophysiolgic insomnia |
|
| ExclusionCriteria |
| Details |
1. Patients having insomnia due to severe illness such as cardiac diseases, hypertension, diabetes and other chronic disorders like bronchial asthma,malignancies,liver diseases,chronic renal diseases were excluded from the study
2. Patients with secondary insomnia , alcoholism, exaggeration of previous psychiatric illness (major depression and mania), narcolepsy, breathing related sleep disorder, schizophrenia
3.Patient having night shift duties
4.Pregnant woman and planning to be pregnant in future 6 months or lactating mothers
5.Patient not willing to participate in the clinical trial or written consent |
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in nidra |
In 28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Decrease in symptoms of anidra |
28 Days |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
28/08/2025 |
| 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="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
|
2 Introduction Anidra is condition where a person complaints of loss of Nidra (sleep)during night (its natural time).1 Acharya Charak mentioned 80 nanatmaja vyadhi of vata, Anidra is one them.2 It is a pathological condition. Naidanik bhavas contributing to the condition of Anidra can broadly be listed under Sharirik(somatic),manas (psychological) and Agantuja in origin. These results in accumulation of concerning doshas (rajas, vata, pitta) and simultaneous Tamah and Kapha kshaya in manovaha strotasas. In Anidra mainly vitiation of vata, pitta dosha occurs3. Nidra is one of trividha upsthambas (Ahar,Nidra , Brahmacharya)4. Modern science and Ayurveda recognize the significance of sleep for health and well-being. Ayurveda emphasizes the importance of sleep for mental relaxation and overall health. Insomnia is the complaint of inadequate sleep; it can be classified according to nature of sleep disruption and the duration of the complaint. In insomnia,some patients complaints falling asleep,frequent or sustained awakening,early morning awakenings5. Primary Insomnia is caused by its own set of causative factors, where vata dosha takes a primary role in the manifestation of disease. Anidra explained under vata 80 nanatmaja vyadhi can be considered as primary insomnia.6 Anidra classified first by Charaka as pranashta and nimitta symptoms of anidra are jrumbha , angamarda, tandra, shirogaurav, glani, bhrama, apakti among these most of the symptoms can be correlated with symptom of insomnia given by DSM (Diagnostic and Statistical Manual of mental disorders IV -text revision (DSM IV -TR) such as difficulty initiating or maintaining sleep, non restorative sleep. It indicates acharyas have profound knowledge of physiopathology of insomnia.7Primary insomnia8 is expected to affect approximately 25% of all individuals with chronic insomnia. Long-term use of sedatives like benzodiazepines and newer non-benzodiazepine drugs can result in physical dependence, leading to withdrawal symptoms if abruptly stopped. These medications are associated with side effects such as daytime fatigue, cognitive impairments, and an increased risk of accidents and falls, especially in elderly individuals. Research suggests that chronic use of these medications for insomnia may not necessarily improve sleep quality compared to those not taking them. In fact, chronic users may experience more regular night time awakenings.9 Pippalimoola, the root of the long pepper plant, is acknowledged as an effective remedy for anidra (primary Insomnia). In the Vangsen Samhita10 specifically Chapter on Jwaradikara, Guda Pippalimoola Churna is cited as a treatment for anidra (primary insomnia) patients. Acharya Bhavamishra11recommends Pippalimoola as a sedative medication in the Chikitsa Sthana. Additionally, Bhaishajya Ratnavali12also advocate the use of Pippalimoola mixed with guda at night for individuals with anidra (Primary insomnia). Need for Study: In today’s era, patients prefer readily available, cost-effective, and easily consumable drugs with minimal side effects for their health issues. Therefore, there is a pressing need to develop herbal formulations that can effectively treat Primary Insomnia with minimal adverse effects over the long term. Pippali is katu rasatmak, Ushna Virya and Madhura vipaki. Acharyas consider this drug in shirovirechanopag varga. It is used as a brain tonic and balances Vata dosha. Pippali can be used to manage anidra . This is because according to Ayurveda, anidra is caused by an aggravated Vata and Pippali has Vata balancing property. Pippali churna can be used to manage anidra (primary insomnia)13. It is due to the sedative property of extracts from Pippali fruits and roots that causes drowsiness and therefore induces sleep. Pippali churna along with guda and dugdha can be taken in the evening after meals for the management of anidra (primary insomnia)14.Tagara is useful to induce sound sleep. According to Ayurveda, an aggravated Vata dosha makes the nervous system sensitive which leads to Anidra (Primary Insomnia). Tagara calms the nervous system due to its Tridosha balancing property, especially Vata balancing, thereby helping in the management of Anidra (Primary Insomnia). Tagara might be useful in managing anidra. It reduces the activity of a certain chemical in the brain that helps in calming down brain activity which helps induce sleep. As Tagara has sedative activity, it is advisable not to take this along with sedatives or CNS depressants as it might prolong the drowsiness.15 Approximately there are 4 previous works have been done on Guda Pippalimoola Churna and 3 previous works have been done on Tagara churna.Taking this into account the purpose of comparative study is to compare the efficacy of these two drugs.As Both drugs are cost effective, palatable and easily available. Hence topic is selected Randomized comparative clinical study of Guda Pippalimoola Churna and Tagara Churna in Anidra w.s.r to Primary Insomnia
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